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Trial record 92 of 214 for:    TETRACYCLINE

Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00927186
Recruitment Status : Completed
First Posted : June 24, 2009
Results First Posted : March 2, 2012
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Osteoporosis, Post-menopausal
Interventions Drug: Teriparatide
Drug: Zoledronic Acid
Enrollment 69
Recruitment Details  
Pre-assignment Details This was a Phase 4, multicenter, randomized, stratified, double-blind, active comparator-controlled study with the primary endpoint at 6 months. Following the bone biopsy visit at 6 months, the study became open label for an additional 6 months. All participants who complete 12 months of treatment are eligible for an additional 12-month extension.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Period Title: 12 Months Primary Study
Started 34 35
Completed 6 Months Double Blind Phase 28 31
Completed 27 31
Not Completed 7 4
Reason Not Completed
Adverse Event             5             2
Lost to Follow-up             1             0
Protocol Violation             0             1
Withdrawal by Subject             1             1
Period Title: 12 - 24 Months Extension Treatment
Started 10 [1] 11 [1]
Completed 10 11
Not Completed 0 0
[1]
Not all participants who completed 12 months of primary study chose to enter 12-month extension.
Arm/Group Title Teriparatide Zoledronic Acid Total
Hide Arm/Group Description 20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension. 5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension. Total of all reporting groups
Overall Number of Baseline Participants 34 35 69
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 35 participants 69 participants
65.49  (6.93) 64.20  (5.96) 64.84  (6.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 69 participants
Female
34
 100.0%
35
 100.0%
69
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 69 participants
Black or African American 1 1 2
White 33 34 67
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 69 participants
United States 21 25 46
Canada 13 10 23
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 34 participants 35 participants 69 participants
159.28  (5.92) 160.00  (7.38) 159.64  (6.66)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 34 participants 35 participants 69 participants
61.25  (9.21) 64.75  (11.66) 63.03  (10.60)
Pulse  
Mean (Standard Deviation)
Unit of measure:  Beats per minute (bpm)
Number Analyzed 34 participants 35 participants 69 participants
67.41  (7.15) 70.60  (8.79) 69.03  (8.13)
Blood Pressure - Systolic  
Mean (Standard Deviation)
Unit of measure:  Millimeters of mercury (mmHg)
Number Analyzed 34 participants 35 participants 69 participants
125.71  (16.19) 122.49  (16.25) 124.07  (16.18)
Blood Pressure - Diastolic  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 34 participants 35 participants 69 participants
74.79  (8.24) 73.97  (10.15) 74.38  (9.20)
Alcohol Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 69 participants
Yes 21 17 38
No 13 18 31
Tobacco Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 69 participants
Yes 5 5 10
No 29 30 59
Caffeine or Xanthine Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 69 participants
Yes 29 30 59
No 5 5 10
Previous Osteoporosis Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 69 participants
Yes 17 21 38
No 17 14 31
Fracture Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 69 participants
Yes 14 17 31
No 20 18 38
[1]
Measure Description: Yes means a participant has already had fracture before study entry.
Lumbar Spine T-Score   [1] 
Mean (Standard Deviation)
Unit of measure:  T-Score
Number Analyzed 34 participants 35 participants 69 participants
-2.79  (0.83) -2.93  (0.75) -2.86  (0.79)
[1]
Measure Description: The T-score at lumbar spine is a comparison of a participant's bone mineral density (BMD) to that of the mean BMD for a healthy population of women at peak bone mass (30 years). A normal T-score has a value of -1.0 or higher. Osteoporosis is defined as a T-score of -2.5 or lower, meaning a bone mineral density that is two and a half standard deviations below the mean BMD of a healthy population of women at peak bone mass (30 years).
Femoral Neck T-Score   [1] 
Mean (Standard Deviation)
Unit of measure:  T-Score
Number Analyzed 34 participants 35 participants 69 participants
-2.25  (0.68) -2.29  (0.74) -2.27  (0.70)
[1]
Measure Description: The T-score at femoral neck is a comparison of a participant's bone mineral density (BMD) to that of the mean BMD for a healthy population of women at peak bone mass (30 years). A normal T-score has a value of -1.0 or higher. Osteoporosis is defined as a T-score of -2.5 or lower, meaning a bone mineral density that is two and a half standard deviations below the mean BMD of a healthy population of women at peak bone mass (30 years).
Total Hip T-Score   [1] 
Mean (Standard Deviation)
Unit of measure:  T-Score
Number Analyzed 34 participants 35 participants 69 participants
-1.78  (0.78) -1.88  (0.91) -1.83  (0.84)
[1]
Measure Description: The T-score at total hip is a comparison of a participant's bone mineral density (BMD) to that of the mean BMD for a healthy population of women at peak bone mass (30 years). A normal T-score has a value of -1.0 or higher. Osteoporosis is defined as a T-score of -2.5 or lower, meaning a bone mineral density that is two and a half standard deviations below the mean BMD of a healthy population of women at peak bone mass (30 years).
Serum Procollagen Type I N-Terminal Propeptide (PINP)   [1] 
Mean (Standard Deviation)
Unit of measure:  microgram/Liter (µg/L)
Number Analyzed 34 participants 35 participants 69 participants
49.18  (18.28) 52.88  (19.43) 51.03  (18.81)
[1]
Measure Description: A measure of bone formation.
Serum Carboxyterminal Cross-Linking Telopeptide of Collagen Type I (CTX)   [1] 
Mean (Standard Deviation)
Unit of measure:  Nanogram/milliliter (ng/mL)
Number Analyzed 34 participants 35 participants 69 participants
0.43  (0.23) 0.42  (0.19) 0.43  (0.21)
[1]
Measure Description: A measure of bone resorption.
Serum Osteocalcin   [1] 
Mean (Standard Deviation)
Unit of measure:  microgram/Liter (µg/L)
Number Analyzed 34 participants 35 participants 69 participants
25.05  (8.37) 24.92  (8.53) 24.98  (8.39)
[1]
Measure Description: A measure of osteoblast function.
1.Primary Outcome
Title Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months
Hide Description MS/BS in CC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 30
Median (Inter-Quartile Range)
Unit of Measure: percentage of surface
5.60
(3.00 to 11.75)
0.16
(0.00 to 0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The pre-specified significance level 0.05 was used.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months
Hide Description MS/BS in CC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had MS/BS analysis of the CC at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: percentage of surface
3.00
(1.49 to 4.58)
0.07
(0.00 to 0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description MS/BS in EC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.
Time Frame 6 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had MS/BS analysis of the EC at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of surface
6 months (n=23, 29)
18.64
(9.25 to 21.96)
0.30
(0.00 to 0.84)
24 months (n=9, 8)
5.82
(3.10 to 7.08)
0.00
(0.00 to 0.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is for 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months
Hide Description Ac.f in CC represents the frequency of activation of new remodeling cycles on BS (bone formation rate [BFR]/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 micrometer (µm)/day or counted as missing.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 30
Median (Inter-Quartile Range)
Unit of Measure: new cycles/year
DL and NL (n=28, 28)
0.37
(0.17 to 0.82)
0.01
(0.00 to 0.04)
DL, Imputed SL (ISL) and NL (n=28, 30)
0.37
(0.17 to 0.82)
0.01
(0.00 to 0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months
Hide Description Ac.f in CC represents the frequency of activation of new remodeling cycles on the bone surface (BFR/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had Ac.f analysis of the CC at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: new cycles/year
DL and NL (n=9, 6)
0.19
(0.10 to 0.20)
0.00
(0.00 to 0.02)
DL, Imputed SL (ISL) and NL (n=10, 9)
0.18
(0.08 to 0.20)
0.00
(0.00 to 0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Activation Frequency (Ac.f) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description Ac.f in EC represents the frequency of activation of new remodeling cycles on the bone surface (BFR/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had Ac.f analysis of the EC at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 29
Median (Inter-Quartile Range)
Unit of Measure: new cycles/year
DL and NL at 6 Months (n=23, 20)
0.83
(0.49 to 1.09)
0.00
(0.00 to 0.07)
DL, Imputed SL (ISL) and NL at 6 Months (n=23, 29)
0.83
(0.49 to 1.09)
0.01
(0.00 to 0.04)
DL and NL at 24 Months (n=8, 7)
0.25
(0.18 to 0.31)
0.00
(0.00 to 0.07)
DL, ISL and NL at 24 Months (n=9, 8)
0.24
(0.14 to 0.29)
0.00
(0.00 to 0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is for double labels (DL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months
Hide Description BFR in CC is the volume of mineralized bone formed per unit surface bone per unit time (cubic millimeter/square millimeter/year [mm³/mm²/year]); calculated as mineral apposition rate (MAR) times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 30
Median (Inter-Quartile Range)
Unit of Measure: mm³/mm²/year
DL and NL (n=28, 28)
0.0116
(0.0051 to 0.0265)
0.0002
(0.0000 to 0.0010)
DL, ISL and NL (n=28, 30)
0.0116
(0.0051 to 0.0265)
0.0002
(0.0000 to 0.0010)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months
Hide Description BFR in CC is the volume of mineralized bone formed per unit surface bone per unit time (mm³/mm²/year); calculated as MAR times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had BFR analysis of the CC at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: mm³/mm²/year
DL and NL (n=9, 6)
0.0057
(0.0033 to 0.0061)
0.0000
(0.0000 to 0.0005)
DL, Imputed SL (ISL) and NL (n=10, 9)
0.0057
(0.0022 to 0.0061)
0.0001
(0.0000 to 0.0005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Bone Formation Rate (BFR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description BFR in EC is the volume of mineralized bone formed per unit surface bone per unit time (mm³/mm²/year); calculated as MAR times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had BFR analysis of EC at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 29
Median (Inter-Quartile Range)
Unit of Measure: mm³/mm²/year
DL and NL at 6 Months (n=23, 20)
0.0307
(0.0182 to 0.0411)
0.0000
(0.0000 to 0.0022)
DL, Imputed SL (ISL) and NL at 6 Months (n=23, 29)
0.0307
(0.0182 to 0.0411)
0.0003
(0.0000 to 0.0014)
DL and NL at 24 Months (n=8, 7)
0.0093
(0.0064 to 0.0109)
0.0000
(0.0000 to 0.0027)
DL, ISL and NL at 24 Months (n=9, 8)
0.0090
(0.0049 to 0.0100)
0.0000
(0.0000 to 0.0016)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value is for double labels (DL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months
Hide Description MAR in CC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive T labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 30
Median (Inter-Quartile Range)
Unit of Measure: micrometer (µm)/day
DL and NL (n=28, 28)
0.56
(0.48 to 0.62)
0.35
(0.00 to 0.51)
DL, ISL and NL (n=28, 30)
0.56
(0.48 to 0.62)
0.33
(0.00 to 0.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months
Hide Description MAR in CC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had MAR analysis of the CC at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: micrometer (µm)/day
DL and NL (n=9, 6)
0.44
(0.40 to 0.52)
0.00
(0.00 to 0.34)
DL, Imputed SL (ISL) and NL (n=10, 9)
0.43
(0.37 to 0.52)
0.30
(0.00 to 0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Mineral Apposition Rate (MAR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description MAR in EC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had MAR analysis of the EC at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 29
Median (Inter-Quartile Range)
Unit of Measure: micrometer (µm/day)
DL and NL at 6 Months (n=23, 20)
0.50
(0.43 to 0.56)
0.00
(0.00 to 0.41)
DL, Imputed SL (ISL) and NL at 6 Months (n=23, 29)
0.50
(0.43 to 0.56)
0.30
(0.00 to 0.30)
DL and NL at 24 Months (n=8, 7)
0.43
(0.38 to 0.50)
0.00
(0.00 to 0.44)
DL, ISL and NL at 24 Months (n=9, 8)
0.42
(0.37 to 0.45)
0.00
(0.00 to 0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments P-value is for double labels (DL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title Adjusted Apposition Rate (Aj.AR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months
Hide Description Aj.AR in CC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 30
Median (Inter-Quartile Range)
Unit of Measure: µm/day
DL and NL (n=28, 28)
0.34
(0.15 to 0.51)
0.02
(0.00 to 0.06)
DL, ISL and NL (n=28, 30)
0.34
(0.15 to 0.51)
0.02
(0.00 to 0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title Adjusted Apposition Rate (Aj.AR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months
Hide Description Aj.AR in CC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had Aj.AR analysis of the CC at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: micrometer (µm)/day
DL and NL (n=9, 6)
0.13
(0.07 to 0.32)
0.00
(0.00 to 0.13)
DL, Imputed SL (ISL) and NL (n=10, 9)
0.12
(0.07 to 0.32)
0.02
(0.00 to 0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
15.Secondary Outcome
Title Adjusted Apposition Rate (Aj.AR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description Aj.AR in EC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had Aj.AR analysis of the EC at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 29
Median (Inter-Quartile Range)
Unit of Measure: micrometer (µm)/day
DL and NL at 6 Months (n=23, 20)
0.41
(0.34 to 0.57)
0.00
(0.00 to 0.05)
DL, Imputed SL (ISL) and NL at 6 Months (n=23, 29)
0.41
(0.34 to 0.57)
0.03
(0.00 to 0.16)
DL and NL at 24 Months (n=8, 7)
0.35
(0.25 to 0.45)
0.00
(0.00 to 0.12)
DL, ISL and NL at 24 Months (n=9, 8)
0.32
(0.19 to 0.45)
0.00
(0.00 to 0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value is for double labels (DL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
16.Secondary Outcome
Title Mineralization Lag Time (Mlt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months
Hide Description Mlt in CC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as Osteoid Thickness (O.Th) divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 30
Median (Inter-Quartile Range)
Unit of Measure: day
DL and NL (n=28, 16)
13.63
(11.22 to 29.22)
75.72
(26.84 to 193.78)
DL, ISL and NL (n=28, 18)
13.63
(11.22 to 29.22)
75.72
(24.99 to 215.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
17.Secondary Outcome
Title Mineralization Lag Time (Mlt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months
Hide Description Mlt in CC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as O.Th divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had Mlt analysis of the CC at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 10 5
Median (Inter-Quartile Range)
Unit of Measure: day
DL and NL (n=9, 2)
38.84
(22.81 to 57.02)
45.67
(37.70 to 53.65)
DL, Imputed SL (ISL) and NL (n=10, 5)
45.33
(22.81 to 81.83)
128.37
(53.65 to 169.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.906
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
18.Secondary Outcome
Title Mineralization Lag Time (Mlt) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description Mlt in EC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as O.Th divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had Mlt analysis of the EC at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 15
Median (Inter-Quartile Range)
Unit of Measure: day
DL and NL at 6 Months (n=23, 6)
12.63
(9.03 to 17.46)
26.97
(24.61 to 72.03)
DL, Imputed SL (ISL) and NL at 6 Months (n=23, 15)
12.63
(9.03 to 17.46)
26.70
(19.84 to 47.31)
DL and NL at 24 Months (n=8, 2)
15.67
(10.56 to 22.99)
42.86
(23.50 to 62.23)
DL, ISL and NL at 24 Months (n=9, 3)
17.04
(11.97 to 23.37)
29.03
(23.50 to 62.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments P-value is for double labels (DL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments P-value is for double labels (DL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.196
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
19.Secondary Outcome
Title Osteoid Maturation Time (Omt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months
Hide Description Omt in CC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 28 30
Median (Inter-Quartile Range)
Unit of Measure: day
DL and NL (n=28, 16)
9.99
(8.39 to 10.74)
9.05
(7.83 to 10.76)
DL, ISL and NL (n=28, 18)
9.99
(8.39 to 10.74)
9.05
(7.97 to 10.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.502
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.597
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
20.Secondary Outcome
Title Osteoid Maturation Time (Omt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months
Hide Description Omt in CC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had Omt analysis of the CC at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 10 5
Median (Inter-Quartile Range)
Unit of Measure: day
DL and NL (n=9, 2)
13.42
(11.62 to 13.72)
17.38
(13.92 to 20.84)
DL, Imputed SL (ISL) and NL (n=10, 5)
13.52
(11.62 to 13.81)
13.92
(13.26 to 18.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.358
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
21.Secondary Outcome
Title Osteoid Maturation Time (Omt) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description Omt in EC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had Omt analysis of the EC at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 15
Median (Inter-Quartile Range)
Unit of Measure: day
DL and NL at 6 Months (n=23, 6)
10.57
(9.67 to 11.06)
11.27
(9.62 to 12.80)
DL, Imputed SL (ISL) and NL at 6 Months (n=23, 15)
10.57
(9.67 to 11.06)
11.34
(9.92 to 16.34)
DL and NL at 24 Months (n=8, 2)
12.30
(9.86 to 16.61)
14.94
(12.12 to 17.76)
DL, ISL and NL at 24 Months (n=9, 3)
13.03
(10.64 to 16.18)
12.12
(9.54 to 17.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.647
Comments P-value is for double labels (DL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.695
Comments P-value is for double labels (DL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
22.Secondary Outcome
Title Total Formation Period (Tt.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months
Hide Description Tt.FP in CC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 30
Median (Inter-Quartile Range)
Unit of Measure: year
DL and NL (n=28, 16)
0.24
(0.16 to 0.50)
1.46
(0.44 to 3.10)
DL, ISL and NL (n=28, 18)
0.24
(0.16 to 0.50)
1.46
(0.44 to 3.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
23.Secondary Outcome
Title Total Formation Period (Tt.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months
Hide Description Tt.FP in CC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had Tt.FP analysis of the CC at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension

Overall Number of Participants Analyzed 10 5
Median (Inter-Quartile Range)
Unit of Measure: year
DL and NL (n=9, 2)
0.60
(0.31 to 1.12)
0.51
(0.39 to 0.63)
DL, Imputed SL (ISL) and NL (n=10, 5)
0.68
(0.31 to 1.15)
2.62
(0.63 to 2.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.198
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
24.Secondary Outcome
Title Total Formation Period (Tt.FP) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description Tt.FP in EC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had Tt.FP analysis of the EC at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 15
Median (Inter-Quartile Range)
Unit of Measure: year
DL and NL at 6 Months (n=23, 6)
0.24
(0.17 to 0.30)
0.43
(0.30 to 1.62)
DL, Imputed SL (ISL) and NL at 6 Months (n=23, 15)
0.24
(0.17 to 0.30)
0.54
(0.32 to 1.37)
DL and NL at 24 Months (n=8, 2)
0.27
(0.22 to 0.43)
0.62
(0.38 to 0.86)
DL, ISL and NL at 24 Months (n=9, 3)
0.31
(0.22 to 0.50)
0.86
(0.38 to 0.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments P-value is for double labels (DL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments P-value is for double labels (DL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.139
Comments -value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
25.Secondary Outcome
Title Active Formation Period (a.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months
Hide Description a. FP in CC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 30
Median (Inter-Quartile Range)
Unit of Measure: year
DL and NL (n=28, 16)
0.15
(0.14 to 0.17)
0.16
(0.15 to 0.19)
DL, ISL and NL (n=28, 18)
0.15
(0.14 to 0.17)
0.16
(0.15 to 0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.154
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
26.Secondary Outcome
Title Active Formation Period (a.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months
Hide Description a. FP in CC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had a.FP analysis of the CC at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 10 5
Median (Inter-Quartile Range)
Unit of Measure: year
DL and NL (n=9, 2)
0.19
(0.17 to 0.22)
0.19
(0.14 to 0.25)
DL, Imputed SL (ISL) and NL (n=10, 5)
0.19
(0.17 to 0.22)
0.25
(0.24 to 0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.906
Comments P-value is for double labels (DL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
27.Secondary Outcome
Title Active Formation Period (a.FP) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description a. FP in EC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3 day-periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.
Time Frame 6 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had a.FP analysis of the EC at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 15
Median (Inter-Quartile Range)
Unit of Measure: year
DL and NL at 6 Months (n=23, 6)
0.20
(0.17 to 0.22)
0.20
(0.16 to 0.25)
DL, Imputed SL (ISL) and NL at 6 Months (n=23, 15)
0.20
(0.17 to 0.22)
0.28
(0.21 to 0.32)
DL and NL at 24 Months (n=8, 2)
0.23
(0.21 to 0.26)
0.22
(0.20 to 0.25)
DL, ISL and NL at 24 Months (n=9, 3)
0.24
(0.21 to 0.27)
0.25
(0.20 to 0.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.979
Comments P-value is for double labels (DL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.695
Comments P-value is for double labels (DL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.853
Comments P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
28.Secondary Outcome
Title Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months
Hide Description The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the cancellous compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 30
Median (Inter-Quartile Range)
Unit of Measure: percentage of tetracycline labels
sLS/BS
3.19
(1.58 to 4.86)
0.02
(0.00 to 0.38)
dLS/BS
4.13
(2.14 to 8.88)
0.07
(0.00 to 0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for sLS/BS.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for dLS/BS.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
29.Secondary Outcome
Title Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months
Hide Description The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the cancellous compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had sLS/BS and dLS/BS analysis of the cancellous compartment at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: percentage of tetracycline labels
sLS/BS
2.25
(1.27 to 2.90)
0.15
(0.00 to 0.42)
dLS/BS
1.69
(0.41 to 3.69)
0.00
(0.00 to 0.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments P-value is for sLS/BS.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value is for dLS/BS.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
30.Secondary Outcome
Title Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the endocortical compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.
Time Frame 6 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had sLS/BS and dLS/BS analysis of the endocortical compartment at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of tetracycline labels
sLS/BS at 6 months (n=23, 29)
5.56
(3.42 to 8.06)
0.25
(0.00 to 1.42)
dLS/BS at 6 months (n=23, 29)
13.46
(6.04 to 18.68)
0.00
(0.00 to 0.00)
sLS/BS at 24 months (n=9, 8)
3.75
(3.16 to 5.69)
0.00
(0.00 to 1.12)
dLS/BS at 24 months (n=9, 8)
2.77
(0.95 to 2.98)
0.00
(0.00 to 0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for sLS/BS at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for dLS/BS at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments P-value is for sLS/BS at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments P-value is for dLS/BS at 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
31.Secondary Outcome
Title Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months
Hide Description Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the cancellous compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 30
Measure Type: Number
Unit of Measure: samples
No Label 0 12
Single Label Only 0 2
Double Label Only 0 3
Single and Double Label 28 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is a comparison of "No Label" vs. "Single, Double, Single and Double Label".
Method Fisher Exact
Comments [Not Specified]
32.Secondary Outcome
Title Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months
Hide Description Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the cancellous compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy of the cancellous compartment at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 10 9
Measure Type: Number
Unit of Measure: samples
No Label 0 4
Single Label Only 1 3
Double Label Only 0 0
Single and Double Label 9 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments P-value is a comparison of "No Label" vs. "Single, Double, Single and Double Label".
Method Fisher Exact
Comments [Not Specified]
33.Secondary Outcome
Title Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the endocortical compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.
Time Frame 6 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy of the endocortical compartment at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 29
Measure Type: Number
Unit of Measure: samples
No Label at 6 months (n=23, 29) 0 14
Single Label Only at 6 months (n=23, 29) 0 9
Double Label Only at 6 months (n=23, 29) 0 0
Single and Double Label at 6 months (n=23, 29) 23 6
No Label at 24 months (n=9, 8) 0 5
Single Label Only at 24 months (n=9, 8) 1 1
Double Label Only at 24 months (n=9, 8) 0 0
Single and Double Label at 24 months (n=9, 8) 8 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is a comparison of "No Label" vs. "Single, Double, Single and Double Label" at 6 months.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments P-value is a comparison of "No Label" vs. "Single, Double, Single and Double Label" at 24 months.
Method Fisher Exact
Comments [Not Specified]
34.Secondary Outcome
Title Average Length of Tetracycline Double Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months
Hide Description The length of tetracycline double labels is a measure of the extent of bone formation in the cancellous compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 16
Median (Inter-Quartile Range)
Unit of Measure: millimeter (mm)
0.35
(0.28 to 0.38)
0.24
(0.19 to 0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
35.Secondary Outcome
Title Average Length of Tetracycline Double Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months
Hide Description The length of tetracycline double labels is a measure of the extent of bone formation in the cancellous compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had length of tetracycline double labels analysis of the cancellous compartment at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 9 2
Median (Inter-Quartile Range)
Unit of Measure: millimeter (mm)
0.23
(0.22 to 0.29)
0.29
(0.19 to 0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.906
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
36.Secondary Outcome
Title Average Length of Tetracycline Double Labels in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description The length of tetracycline double labels is a measure of the extent of bone formation in the endocortical compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.
Time Frame 6 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had length of tetracycline double labels analysis of the endocortical compartment at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 6
Median (Inter-Quartile Range)
Unit of Measure: millimeter (mm)
6 months (n=23, 6)
0.34
(0.27 to 0.39)
0.30
(0.24 to 0.39)
24 months (n=8, 2)
0.27
(0.24 to 0.43)
0.30
(0.24 to 0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.536
Comments P-value is for 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.896
Comments P-value is for 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
37.Secondary Outcome
Title Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months
Hide Description Osteoid volume (OV) in the cancellous compartment is the percent of a given volume of bone tissue that consists of unmineralized bone (osteoid).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 30
Median (Inter-Quartile Range)
Unit of Measure: percentage of volume
1.32
(0.81 to 2.13)
0.24
(0.08 to 0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
38.Secondary Outcome
Title Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months
Hide Description Osteoid volume (OV) in the cancellous compartment is the percent of a given volume of bone tissue that consists of unmineralized bone (osteoid).
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had OV/BV analysis of the CC at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: percentage of volume
1.33
(0.89 to 1.56)
0.18
(0.05 to 0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
39.Secondary Outcome
Title Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months
Hide Description Osteoid surface (OS) in the cancellous compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 30
Median (Inter-Quartile Range)
Unit of Measure: percentage of surface
11.34
(6.58 to 16.52)
2.51
(1.27 to 4.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
40.Secondary Outcome
Title Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months
Hide Description Osteoid surface (OS) in the cancellous compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had OS/BS analysis of the CC at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: percentage of surface
11.19
(7.23 to 13.14)
1.26
(0.72 to 2.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
41.Secondary Outcome
Title Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description Osteoid surface (OS) in the endocortical compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.
Time Frame 6 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had OS/BS analysis of the EC at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of surface
6 months (n=23, 29)
16.33
(13.57 to 24.34)
1.87
(1.08 to 3.99)
24 months (n=9, 8)
7.48
(6.39 to 10.10)
1.55
(1.19 to 3.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments P-value is for 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
42.Secondary Outcome
Title Osteoid Thickness (OTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months
Hide Description Osteoid thickness (OTh.) in the cancellous compartment is a measure of the average thickness of osteoid seams.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:
20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
Overall Number of Participants Analyzed 28 30
Median (Inter-Quartile Range)
Unit of Measure: micrometer (µm)
4.92
(4.29 to 6.68)
3.77
(3.51 to 4.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
43.Secondary Outcome
Title Osteoid Thickness (OTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months
Hide Description Osteoid thickness (OTh.) in the cancellous compartment is a measure of the average thickness of osteoid seams.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had OTh. analysis of the CC at 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
Hide Arm/Group Description:

20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 10 9
Median (Inter-Quartile Range)
Unit of Measure: micrometer (µm)
5.71
(4.68 to 6.15)
3.98
(3.48 to 5.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
44.Secondary Outcome
Title Osteoid Thickness (OTh.) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months
Hide Description Osteoid thickness (OTh.) in the endocortical compartment is a measure of the average thickness of osteoid seams.
Time Frame 6 and 24 months
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Hide Analysis Population Description
All participants who received at least one dose of study drug with an evaluable bone biopsy and had OTh. analysis of the EC at 6 and 24 months.
Arm/Group Title Teriparatide Zoledronic Acid
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20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Overall Number of Participants Analyzed 23 29
Median (Inter-Quartile Range)
Unit of Measure: micrometer (µm)
6 months (n=23, 29)
4.94
(4.41 to 5.87)
3.70
(2.99 to 4.82)
24 months (n=9, 8)
5.23
(4.22 to 7.24)
3.53
(3.21 to 5.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide, Zoledronic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments P-value is for 24 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
45.Secondary Outcome
Title Wall Thickness (WTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months
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