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Enhancing Osteoporosis Therapy: Can We Open the Anabolic Window?

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ClinicalTrials.gov Identifier: NCT01166958
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : September 22, 2014
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoporosis
Interventions Drug: Teriparatide
Drug: Raloxifene
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Daily Teriparatide (Forteo) Monthly Cycles of Teriparatide Followed by Raloxifene
Hide Arm/Group Description Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.

Period Title: Overall Study
Started 13 13
Completed 12 13
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Daily Teriparatide (Forteo) Monthly Cycles of Teriparatide Followed by Raloxifene Total
Hide Arm/Group Description Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.

Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
67.7
(61.2 to 83.1)
66.2
(56.0 to 78.8)
67.0
(56.0 to 83.1)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  30.8%
7
  53.8%
11
  42.3%
>=65 years
9
  69.2%
6
  46.2%
15
  57.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
13
 100.0%
13
 100.0%
26
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 26 participants
13 13 26
1.Primary Outcome
Title Serum Markers of Skeletal Turnover (Serum CTX)
Hide Description Serum CTX was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.
Time Frame These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daily Teriparatide (Forteo) Monthly Cycles of Teriparatide Followed by Raloxifene
Hide Arm/Group Description:
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.

Overall Number of Participants Analyzed 13 13
Mean (Full Range)
Unit of Measure: ng/mL
0.9887
(0.5989 to 1.4042)
0.5445
(0.433 to 0.5838)
2.Primary Outcome
Title Serum Markers of Skeletal Turnover (Serum P1NP)
Hide Description Serum P1NP was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.
Time Frame These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daily Teriparatide (Forteo) Monthly Cycles of Teriparatide Followed by Raloxifene
Hide Arm/Group Description:
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.

Overall Number of Participants Analyzed 13 13
Mean (Full Range)
Unit of Measure: mcg/L
128.7
(61.3 to 177.9)
83.8
(52.8 to 110.8)
3.Secondary Outcome
Title Average Bone Mineral Density of the Spine at Baseline, 3 Months and 6 Months
Hide Description Spine BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.
Time Frame BMD measured at the baseline, 3 month, and 6 month visits.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daily Teriparatide (Forteo) Monthly Cycles of Teriparatide Followed by Raloxifene
Hide Arm/Group Description:
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.

Overall Number of Participants Analyzed 13 13
Mean (Full Range)
Unit of Measure: g/cm2
0.9599
(0.819 to 1.192)
0.9006
(0.718 to 1.094)
4.Secondary Outcome
Title Average Bone Mineral Density of the Proximal Femur (Hip) at Baseline, 3 Months and 6 Months
Hide Description Hip BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.
Time Frame BMD measured at the baseline, 3 month, and 6 month visits.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daily Teriparatide (Forteo) Monthly Cycles of Teriparatide Followed by Raloxifene
Hide Arm/Group Description:
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.

Overall Number of Participants Analyzed 13 13
Mean (Full Range)
Unit of Measure: g/cm2
0.7951
(0.677 to 0.939)
0.7898
(0.667 to 0.943)
5.Secondary Outcome
Title Average Bone Mineral Density of the One-third Radius at Baseline, 3 Months and 6 Months
Hide Description One-third radius BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.
Time Frame BMD measured at the baseline, 3 month, and 6 month visits.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daily Teriparatide (Forteo) Monthly Cycles of Teriparatide Followed by Raloxifene
Hide Arm/Group Description:
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.

Overall Number of Participants Analyzed 13 13
Mean (Full Range)
Unit of Measure: g/cm2
0.6858
(0.6 to 0.762)
0.687
(0.461 to 0.87)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daily Teriparatide (Forteo) Monthly Cycles of Teriparatide Followed by Raloxifene
Hide Arm/Group Description Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.

All-Cause Mortality
Daily Teriparatide (Forteo) Monthly Cycles of Teriparatide Followed by Raloxifene
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Daily Teriparatide (Forteo) Monthly Cycles of Teriparatide Followed by Raloxifene
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daily Teriparatide (Forteo) Monthly Cycles of Teriparatide Followed by Raloxifene
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Neil Binkley, MD
Organization: University of Wisconsin Osteoporosis Clinical Research Program
Phone: 608-265-6410
EMail: uwosteoporosis@gmail.com
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01166958    
Other Study ID Numbers: H-2010-0064
First Submitted: July 15, 2010
First Posted: July 21, 2010
Results First Submitted: June 18, 2014
Results First Posted: September 22, 2014
Last Update Posted: September 22, 2014