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A Study for Patients With Osteoporosis

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: NCT00414973
Recruitment Status : Completed
First Posted : December 22, 2006
Results First Posted : August 26, 2009
Last Update Posted : October 28, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoporosis
Interventions Drug: Teriparatide
Drug: Salmon Calcitonin
Enrollment 364
Recruitment Details  
Pre-assignment Details 364 participants were randomized, but 2 females did not receive study drug and are not included in any of the analyses.
Arm/Group Title Teriparatide - Females Calcitonin - Females Teriparatide - Males Calcitonin - Males
Hide Arm/Group Description Subcutaneous, 20 micrograms/day, 24 weeks Intranasal, 200 International Units (IU)/day, 24 weeks Subcutaneous, 20 micrograms/day, 24 weeks Intranasal, 200 IU/day, 24 weeks
Period Title: Overall Study
Started 218 109 24 11
Completed 190 99 21 11
Not Completed 28 10 3 0
Reason Not Completed
Withdrawal by Subject             14             4             1             0
Adverse Event             10             0             1             0
Protocol Violation             3             4             0             0
Lost to Follow-up             0             2             0             0
Sponsor Decision             1             0             0             0
Death             0             0             1             0
Arm/Group Title Teriparatide - Females Calcitonin - Females Teriparatide - Males Calcitonin - Males Total
Hide Arm/Group Description Subcutaneous, 20 micrograms/day, 24 weeks Intranasal, 200 International Units (IU)/day, 24 weeks Subcutaneous, 20 micrograms/day, 24 weeks Intranasal, 200 IU/day, 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 218 109 24 11 362
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 218 participants 109 participants 24 participants 11 participants 362 participants
69.09  (6.95) 67.81  (7.22) 68.27  (8.28) 67.39  (11.01) 68.60  (7.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 109 participants 24 participants 11 participants 362 participants
Female
218
 100.0%
109
 100.0%
0
   0.0%
0
   0.0%
327
  90.3%
Male
0
   0.0%
0
   0.0%
24
 100.0%
11
 100.0%
35
   9.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 218 participants 109 participants 24 participants 11 participants 362 participants
218 109 24 11 362
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
East Asian Number Analyzed 218 participants 109 participants 24 participants 11 participants 362 participants
218 109 24 11 362
Duration of Osteoporosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 218 participants 109 participants 24 participants 11 participants 362 participants
3.6  (5.33) 3.1  (4.16) 1.9  (2.24) 2.4  (2.54) 3.30  (4.80)
1.Primary Outcome
Title Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women
Hide Description Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Time Frame Baseline to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Intention to Treat patients with baseline and at least one post baseline measurement. Last Observation Carried Forward.
Arm/Group Title Teriparatide - Females Calcitonin - Females
Hide Arm/Group Description:
Subcutaneous, 20 micrograms/day, 24 weeks
Intranasal, 200 IU/day, 24 weeks
Overall Number of Participants Analyzed 201 102
Least Squares Mean (Standard Error)
Unit of Measure: percentage change in lumbar spine BMD
6.04  (0.48) 1.65  (0.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide - Females, Calcitonin - Females
Comments Null hypothesis=no difference between percentage changes from baseline in lumbar spine bone mineral density for female patients receiving teriparatide compared to female patients receiving calcitonin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments There were no adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.39
Confidence Interval 95%
2.89 to 5.89
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.76
Estimation Comments Difference = Teriparatide minus Calcitonin
2.Secondary Outcome
Title Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women
Hide Description Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Time Frame Baseline to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.
Arm/Group Title Teriparatide - Females Calcitonin - Females
Hide Arm/Group Description:
Subcutaneous, 20 micrograms/day, 24 weeks
Intranasal, 200 IU/day, 24 weeks
Overall Number of Participants Analyzed 205 104
Least Squares Mean (Standard Error)
Unit of Measure: percentage change in total hip BMD
-0.53  (0.44) -0.62  (0.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide - Females, Calcitonin - Females
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9062
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.08
Confidence Interval 95%
-1.30 to 1.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.70
Estimation Comments Difference = Teriparatide minus Calcitonin
3.Secondary Outcome
Title Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women
Hide Description Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.
Time Frame Baseline to 12 weeks and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Intention to Treat patients with measurements at respective visits.
Arm/Group Title Teriparatide - Females Calcitonin - Females
Hide Arm/Group Description:
Subcutaneous, 20 micrograms/day, 24 weeks
Intranasal, 200 IU/day, 24 weeks
Overall Number of Participants Analyzed 218 109
Median (Inter-Quartile Range)
Unit of Measure: percentage change in osteocalcin
Week 12 Percentage Change (n=202, n=102)
113.87
(61.20 to 175.94)
-7.67
(-20.51 to 12.56)
Week 24 Percentage Change (n=191, n=97)
137.45
(74.34 to 261.68)
-10.58
(-25.69 to 7.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide - Females, Calcitonin - Females
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value for Week 12 Percentage Change.
Method Wilcoxon Rank-Sum Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide - Females, Calcitonin - Females
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value for Week 24 Percentage Change.
Method Wilcoxon Rank-Sum Test
Comments [Not Specified]
4.Secondary Outcome
Title Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men
Hide Description Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Time Frame Baseline to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.
Arm/Group Title Teriparatide - Males Calcitonin - Males
Hide Arm/Group Description:
Subcutaneous, 20 micrograms/day, 24 weeks
Intranasal, 200 IU/day, 24 weeks
Overall Number of Participants Analyzed 21 10
Least Squares Mean (Standard Error)
Unit of Measure: percentage change in lumbar spine BMD
6.01  (1.20) 3.38  (1.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide - Males, Calcitonin - Males
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2409
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.63
Confidence Interval 95%
-1.87 to 7.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.20
Estimation Comments Difference = Teriparatide minus Calcitonin
5.Secondary Outcome
Title Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men
Hide Description Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Time Frame Baseline to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.
Arm/Group Title Teriparatide - Males Calcitonin - Males
Hide Arm/Group Description:
Subcutaneous, 20 micrograms/day, 24 weeks
Intranasal, 200 IU/day, 24 weeks
Overall Number of Participants Analyzed 21 11
Least Squares Mean (Standard Error)
Unit of Measure: percentage change in total hip BMD
0.37  (1.11) 1.34  (1.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide - Males, Calcitonin - Males
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6156
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.96
Confidence Interval 95%
-4.85 to 2.92
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.90
Estimation Comments Difference = Teriparatide minus Calcitonin
6.Secondary Outcome
Title Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men
Hide Description Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.
Time Frame Baseline to 12 weeks and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Intention to Treat patients with measurements at respective visit.
Arm/Group Title Teriparatide - Males Calcitonin - Males
Hide Arm/Group Description:
Subcutaneous, 20 micrograms/day, 24 weeks
Intranasal, 200 IU/day, 24 weeks
Overall Number of Participants Analyzed 24 11
Median (Inter-Quartile Range)
Unit of Measure: percentage change in osteocalcin
Week 12 Percentage Change (n=21, n=11)
107.27
(45.16 to 181.85)
4.35
(-15.83 to 18.95)
Week 24 Percentage Change (n=21, n=11)
79.26
(13.06 to 142.86)
-17.65
(-27.95 to 3.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide - Males, Calcitonin - Males
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0026
Comments P-value for Week 12 Percentage Change.
Method Wilcoxon Rank-Sum Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Teriparatide - Males, Calcitonin - Males
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments P-value for 24 Week Percentage Change.
Method Wilcoxon Rank-Sum Test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Teriparatide - Females Calcitonin - Females Teriparatide - Males Calcitonin - Males
Hide Arm/Group Description Subcutaneous, 20 micrograms/day, 24 weeks Intranasal, 200 International Units (IU)/day, 24 weeks Subcutaneous, 20 micrograms/day, 24 weeks Intranasal, 200 IU/day, 24 weeks
All-Cause Mortality
Teriparatide - Females Calcitonin - Females Teriparatide - Males Calcitonin - Males
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Teriparatide - Females Calcitonin - Females Teriparatide - Males Calcitonin - Males
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8      1      2      0    
Cardiac disorders         
Acute myocardial infarction  1  1/217 (0.46%)  1 0/110 (0.00%)  0 0/24 (0.00%)  0 0/11 (0.00%)  0
Angina pectoris  1  1/217 (0.46%)  1 0/110 (0.00%)  0 0/24 (0.00%)  0 0/11 (0.00%)  0
Atrial fibrillation  1  1/217 (0.46%)  1 0/110 (0.00%)  0 0/24 (0.00%)  0 0/11 (0.00%)  0
Cardiac discomfort  1  1/217 (0.46%)  1 0/110 (0.00%)  0 0/24 (0.00%)  0 0/11 (0.00%)  0
Cardiac disorder  1  1/217 (0.46%)  1 0/110 (0.00%)  0 0/24 (0.00%)  0 0/11 (0.00%)  0
Heart valve incompetence  1  1/217 (0.46%)  1 0/110 (0.00%)  0 0/24 (0.00%)  0 0/11 (0.00%)  0
Gastrointestinal disorders         
Haemorrhoidal haemorrhage  1  1/217 (0.46%)  1 0/110 (0.00%)  0 0/24 (0.00%)  0 0/11 (0.00%)  0
General disorders         
Multi-organ failure  1  0/217 (0.00%)  0 0/110 (0.00%)  0 1/24 (4.17%)  1 0/11 (0.00%)  0
Infections and infestations         
Pneumonia  1  1/217 (0.46%)  1 0/110 (0.00%)  0 0/24 (0.00%)  0 0/11 (0.00%)  0
Sinusitis fungal  1  1/217 (0.46%)  1 0/110 (0.00%)  0 0/24 (0.00%)  0 0/11 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Multiple myeloma  1  0/217 (0.00%)  0 0/110 (0.00%)  0 1/24 (4.17%)  1 0/11 (0.00%)  0
Nervous system disorders         
Cerebral infarction  1  0/217 (0.00%)  0 0/110 (0.00%)  0 1/24 (4.17%)  1 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/217 (0.46%)  1 0/110 (0.00%)  0 0/24 (0.00%)  0 0/11 (0.00%)  0
Bronchitis chronic  1  1/217 (0.46%)  1 0/110 (0.00%)  0 0/24 (0.00%)  0 0/11 (0.00%)  0
Pleural effusion  1  0/217 (0.00%)  0 1/110 (0.91%)  1 0/24 (0.00%)  0 0/11 (0.00%)  0
Pulmonary infarction  1  0/217 (0.00%)  0 0/110 (0.00%)  0 1/24 (4.17%)  1 0/11 (0.00%)  0
Vascular disorders         
Arteriosclerosis obliterans  1  1/217 (0.46%)  1 0/110 (0.00%)  0 0/24 (0.00%)  0 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Teriparatide - Females Calcitonin - Females Teriparatide - Males Calcitonin - Males
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   67      26      7      0    
Cardiac disorders         
Palpitations  1  6/217 (2.76%)  8 1/110 (0.91%)  1 0/24 (0.00%)  0 0/11 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea  1  2/217 (0.92%)  2 2/110 (1.82%)  3 1/24 (4.17%)  1 0/11 (0.00%)  0
Nausea  1  11/217 (5.07%)  15 0/110 (0.00%)  0 0/24 (0.00%)  0 0/11 (0.00%)  0
General disorders         
Asthenia  1  3/217 (1.38%)  3 0/110 (0.00%)  0 1/24 (4.17%)  1 0/11 (0.00%)  0
Thirst  1  1/217 (0.46%)  1 0/110 (0.00%)  0 1/24 (4.17%)  1 0/11 (0.00%)  0
Infections and infestations         
Nasopharyngitis  1  7/217 (3.23%)  7 4/110 (3.64%)  5 1/24 (4.17%)  1 0/11 (0.00%)  0
Injury, poisoning and procedural complications         
Clavicle fracture  1  0/217 (0.00%)  0 0/110 (0.00%)  0 1/24 (4.17%)  1 0/11 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  0/217 (0.00%)  0 1/110 (0.91%)  1 1/24 (4.17%)  1 0/11 (0.00%)  0
Aspartate aminotransferase increased  1  0/217 (0.00%)  0 0/110 (0.00%)  0 1/24 (4.17%)  1 0/11 (0.00%)  0
Blood alkaline phosphatase increased  1  10/217 (4.61%)  10 1/110 (0.91%)  1 1/24 (4.17%)  1 0/11 (0.00%)  0
Blood creatine phosphokinase increased  1  2/217 (0.92%)  2 1/110 (0.91%)  1 1/24 (4.17%)  1 0/11 (0.00%)  0
Blood uric acid increased  1  10/217 (4.61%)  10 0/110 (0.00%)  0 1/24 (4.17%)  1 0/11 (0.00%)  0
Gamma-glutamyltransferase increased  1  1/217 (0.46%)  1 1/110 (0.91%)  1 1/24 (4.17%)  1 0/11 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  6/217 (2.76%)  8 1/110 (0.91%)  3 0/24 (0.00%)  0 0/11 (0.00%)  0
Muscle spasms  1  12/217 (5.53%)  19 4/110 (3.64%)  8 0/24 (0.00%)  0 0/11 (0.00%)  0
Pain in extremity  1  10/217 (4.61%)  19 2/110 (1.82%)  3 1/24 (4.17%)  1 0/11 (0.00%)  0
Nervous system disorders         
Dizziness  1  16/217 (7.37%)  23 4/110 (3.64%)  5 2/24 (8.33%)  2 0/11 (0.00%)  0
Headache  1  5/217 (2.30%)  7 4/110 (3.64%)  6 0/24 (0.00%)  0 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00414973     History of Changes
Other Study ID Numbers: 10591
B3D-MC-GHDG
First Submitted: December 20, 2006
First Posted: December 22, 2006
Results First Submitted: July 16, 2009
Results First Posted: August 26, 2009
Last Update Posted: October 28, 2009