Trial Outcomes & Findings for Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis (NCT NCT00051558)
NCT ID: NCT00051558
Last Updated: 2009-03-12
Results Overview
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
428 participants
Primary outcome timeframe
18 month endpoint
Results posted on
2009-03-12
Participant Flow
Participant milestones
| Measure |
Teriparatide
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Overall Study
STARTED
|
214
|
214
|
|
Overall Study
COMPLETED
|
123
|
118
|
|
Overall Study
NOT COMPLETED
|
91
|
96
|
Reasons for withdrawal
| Measure |
Teriparatide
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
30
|
18
|
|
Overall Study
Withdrawal by Subject
|
29
|
42
|
|
Overall Study
Death
|
9
|
15
|
|
Overall Study
Lost to Follow-up
|
4
|
13
|
|
Overall Study
Protocol Violation
|
3
|
4
|
|
Overall Study
Protocol Entry Criteria Unmet
|
1
|
2
|
|
Overall Study
Sponsor Decision
|
6
|
1
|
|
Overall Study
Other
|
2
|
1
|
|
Overall Study
Significant Lab Value
|
2
|
0
|
|
Overall Study
Physician Decision
|
5
|
0
|
Baseline Characteristics
Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
Baseline characteristics by cohort
| Measure |
Teriparatide
n=214 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=214 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age < 35 years
|
13 participants
n=5 Participants
|
19 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Age, Customized
35 <= Age < 50 years
|
55 participants
n=5 Participants
|
35 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Age, Customized
50 <= Age < 65 years
|
86 participants
n=5 Participants
|
93 participants
n=7 Participants
|
179 participants
n=5 Participants
|
|
Age, Customized
Age >= 65 years
|
60 participants
1.518 • n=5 Participants
|
67 participants
1.528 • n=7 Participants
|
127 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
345 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
64 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
23 participants
n=5 Participants
|
20 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
72 participants
n=5 Participants
|
73 participants
n=7 Participants
|
145 participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Venezuela
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Origin
Caucasian
|
153 participants
n=5 Participants
|
148 participants
n=7 Participants
|
301 participants
n=5 Participants
|
|
Origin
Non-Caucasian
|
61 participants
n=5 Participants
|
66 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Prior Bisphosphonate User
Yes
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Prior Bisphosphonate User
No
|
194 participants
n=5 Participants
|
194 participants
n=7 Participants
|
388 participants
n=5 Participants
|
|
Baseline Biochemical Markers of Bone Metabolism
Serum N-terminal propeptide of type 1 procollagen
|
46.161 ug/L
STANDARD_DEVIATION 35.471 • n=5 Participants
|
47.235 ug/L
STANDARD_DEVIATION 29.606 • n=7 Participants
|
46.704 ug/L
STANDARD_DEVIATION 32.562 • n=5 Participants
|
|
Baseline Biochemical Markers of Bone Metabolism
Procollagen I carboxy-terminal propeptide
|
166.402 ug/L
STANDARD_DEVIATION 99.625 • n=5 Participants
|
152.109 ug/L
STANDARD_DEVIATION 56.637 • n=7 Participants
|
158.845 ug/L
STANDARD_DEVIATION 79.910 • n=5 Participants
|
|
Baseline Biochemical Markers of Bone Metabolism
Bone-specific alkaline phosphatase
|
9.465 ug/L
STANDARD_DEVIATION 4.522 • n=5 Participants
|
9.711 ug/L
STANDARD_DEVIATION 4.527 • n=7 Participants
|
9.595 ug/L
STANDARD_DEVIATION 4.513 • n=5 Participants
|
|
Baseline Biochemical Markers of Bone Metabolism
Osteocalcin
|
17.130 ug/L
STANDARD_DEVIATION 14.422 • n=5 Participants
|
15.878 ug/L
STANDARD_DEVIATION 10.286 • n=7 Participants
|
16.492 ug/L
STANDARD_DEVIATION 12.468 • n=5 Participants
|
|
Baseline Bone Mineral Density
Lumbar Spine Bone Mineral Density
|
0.845 grams per square centimeters
STANDARD_DEVIATION 0.131 • n=5 Participants
|
0.844 grams per square centimeters
STANDARD_DEVIATION 0.128 • n=7 Participants
|
0.845 grams per square centimeters
STANDARD_DEVIATION 0.129 • n=5 Participants
|
|
Baseline Bone Mineral Density
Total Hip Bone Mineral Density
|
0.744 grams per square centimeters
STANDARD_DEVIATION 0.113 • n=5 Participants
|
0.757 grams per square centimeters
STANDARD_DEVIATION 0.124 • n=7 Participants
|
0.750 grams per square centimeters
STANDARD_DEVIATION 0.119 • n=5 Participants
|
|
Baseline Bone Mineral Density
Femoral Neck Bone Mineral Density
|
0.682 grams per square centimeters
STANDARD_DEVIATION 0.114 • n=5 Participants
|
0.697 grams per square centimeters
STANDARD_DEVIATION 0.119 • n=7 Participants
|
0.689 grams per square centimeters
STANDARD_DEVIATION 0.116 • n=5 Participants
|
|
C-terminal telopeptide of type I collagen
|
3790.483 pmol/L
STANDARD_DEVIATION 2478.189 • n=5 Participants
|
4543.156 pmol/L
STANDARD_DEVIATION 4838.919 • n=7 Participants
|
4185.328 pmol/L
STANDARD_DEVIATION 3907.204 • n=5 Participants
|
PRIMARY outcome
Timeframe: 18 month endpointPopulation: The intention-to-treat analysis was performed using all randomized and treated patients.
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Outcome measures
| Measure |
Teriparatide
n=198 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=195 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
|
0.059 grams per square centimeters
Standard Error 0.006
|
0.028 grams per square centimeters
Standard Error 0.006
|
SECONDARY outcome
Timeframe: 18 month endpointPopulation: The intention-to-treat analysis was performed using all randomized and treated patients (female only subset).
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Outcome measures
| Measure |
Teriparatide
n=160 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=159 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset
|
0.056 grams per square centimeters
Standard Error 0.006
|
0.023 grams per square centimeters
Standard Error 0.006
|
SECONDARY outcome
Timeframe: 3, 6, 12, 18, 24, 36 monthsPopulation: The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Outcome measures
| Measure |
Teriparatide
n=198 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=195 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at Month 36 (N=123,N=112)
|
0.090 grams per square centimeters
Standard Error 0.006
|
0.044 grams per square centimeters
Standard Error 0.007
|
|
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at Month 24 (N=136,N=131)
|
0.081 grams per square centimeters
Standard Error 0.006
|
0.043 grams per square centimeters
Standard Error 0.006
|
|
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at Month 18 (N=156,N=148)
|
0.066 grams per square centimeters
Standard Error 0.005
|
0.031 grams per square centimeters
Standard Error 0.005
|
|
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at Month 12 (N=170,N=159)
|
0.054 grams per square centimeters
Standard Error 0.004
|
0.028 grams per square centimeters
Standard Error 0.004
|
|
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at Month 6 (N=178,N=173)
|
0.034 grams per square centimeters
Standard Error 0.004
|
0.018 grams per square centimeters
Standard Error 0.004
|
|
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at Month 3 (N=183,N=184)
|
0.019 grams per square centimeters
Standard Error 0.004
|
0.012 grams per square centimeters
Standard Error 0.004
|
SECONDARY outcome
Timeframe: 3, 6, 12, and 18 monthsPopulation: The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Outcome measures
| Measure |
Teriparatide
n=172 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=173 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Change from baseline at Month 18 (N=127,N=119)
|
0.062 grams per square centimeters
Standard Error 0.005
|
0.027 grams per square centimeters
Standard Error 0.005
|
|
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Change from baseline at Month 12 (N=139,N=129)
|
0.052 grams per square centimeters
Standard Error 0.004
|
0.024 grams per square centimeters
Standard Error 0.004
|
|
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Change from baseline at Month 6 (N=147,N=139)
|
0.031 grams per square centimeters
Standard Error 0.004
|
0.015 grams per square centimeters
Standard Error 0.004
|
|
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Change from baseline at Month 3 (N=149,N=150)
|
0.017 grams per square centimeters
Standard Error 0.004
|
0.012 grams per square centimeters
Standard Error 0.004
|
SECONDARY outcome
Timeframe: 24 and 36 months and Endpoint at 36 monthsPopulation: The intention-to-treat analysis was performed using all randomized and treated patients. For 24 and 36 month time points, no missing data were imputed. However, at the 36 month endpoint, last observation carried forward analysis was applied.
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Outcome measures
| Measure |
Teriparatide
n=198 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=195 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Change, baseline to 36 month endpoint(N=198,N=195)
|
0.073 grams per square centimeters
Standard Error 0.008
|
0.034 grams per square centimeters
Standard Error 0.008
|
|
Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at 36 months (N=123, N=112)
|
0.090 grams per square centimeters
Standard Error 0.006
|
0.044 grams per square centimeters
Standard Error 0.007
|
|
Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at 24 months (N=136, N=131)
|
0.081 grams per square centimeters
Standard Error 0.006
|
0.043 grams per square centimeters
Standard Error 0.006
|
SECONDARY outcome
Timeframe: 18, 24, 36 months, and 18 and 36 month endpointsPopulation: The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However at the 36 month endpoint, last observation carried forward analysis was applied.
change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
Outcome measures
| Measure |
Teriparatide
n=185 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=177 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Change, baseline to 36 month endpoint(N=185,N=177)
|
0.033 grams per square centimeters
Standard Error 0.006
|
0.017 grams per square centimeters
Standard Error 0.006
|
|
Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at 36 months(N=120,N=113)
|
0.041 grams per square centimeters
Standard Error 0.005
|
0.021 grams per square centimeters
Standard Error 0.005
|
|
Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at 24 months(N=135,N=131)
|
0.030 grams per square centimeters
Standard Error 0.005
|
0.015 grams per square centimeters
Standard Error 0.005
|
|
Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Change, baseline to 18 month endpoint(N=185,N=176)
|
0.024 grams per square centimeters
Standard Error 0.005
|
0.014 grams per square centimeters
Standard Error 0.005
|
|
Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at 18 months (N=156,N=145)
|
0.028 grams per square centimeters
Standard Error 0.005
|
0.017 grams per square centimeters
Standard Error 0.005
|
SECONDARY outcome
Timeframe: 18, 24, 36 months, and 18 and 36 month endpointsPopulation: The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However, at 18 and 36 month endpoints, last observation carried forward analyses were applied.
change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
Outcome measures
| Measure |
Teriparatide
n=185 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=177 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Change, baseline to 36 month endpoint(N=185,N=177)
|
0.032 grams per square centimeters
Standard Error 0.005
|
0.017 grams per square centimeters
Standard Error 0.005
|
|
Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at 36 months(N=120,N=113)
|
0.037 grams per square centimeters
Standard Error 0.005
|
0.020 grams per square centimeters
Standard Error 0.005
|
|
Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at 24 months(N=135,N=131)
|
0.034 grams per square centimeters
Standard Error 0.004
|
0.018 grams per square centimeters
Standard Error 0.004
|
|
Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Change, baseline to 18 month endpoint(N=185,N=176)
|
0.026 grams per square centimeters
Standard Error 0.004
|
0.017 grams per square centimeters
Standard Error 0.004
|
|
Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at 18 months (N=156,N=144)
|
0.027 grams per square centimeters
Standard Error 0.004
|
0.018 grams per square centimeters
Standard Error 0.004
|
SECONDARY outcome
Timeframe: 12, 18, 24, and 36 monthsPopulation: The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.
change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
Outcome measures
| Measure |
Teriparatide
n=185 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=177 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at Month 36 (N=120,N=113)
|
0.041 grams per square centimeters
Standard Error 0.005
|
0.021 grams per square centimeters
Standard Error 0.005
|
|
Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at Month 24 (N=135,N=131)
|
0.030 grams per square centimeters
Standard Error 0.005
|
0.015 grams per square centimeters
Standard Error 0.005
|
|
Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at Month 18 (N=156,N=145)
|
0.028 grams per square centimeters
Standard Error 0.005
|
0.017 grams per square centimeters
Standard Error 0.005
|
|
Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at Month 12 (N=167,N=158)
|
0.026 grams per square centimeters
Standard Error 0.005
|
0.012 grams per square centimeters
Standard Error 0.005
|
SECONDARY outcome
Timeframe: 12, 18, 24, and 36 monthsPopulation: The intention-to-treat analysis was performed using all randomized and treated patients. No missing data was imputed.
change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
Outcome measures
| Measure |
Teriparatide
n=185 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=177 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at 36 Months (N=120, N=113)
|
0.037 grams per square centimeters
Standard Error 0.005
|
0.020 grams per square centimeters
Standard Error 0.005
|
|
Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at 24 Months (N=135, N=131)
|
0.034 grams per square centimeters
Standard Error 0.004
|
0.018 grams per square centimeters
Standard Error 0.004
|
|
Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at 18 Months (N=156, N=145)
|
0.027 grams per square centimeters
Standard Error 0.004
|
0.018 grams per square centimeters
Standard Error 0.004
|
|
Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Change from baseline at 12 Months (N=167, N=158)
|
0.022 grams per square centimeters
Standard Error 0.004
|
0.014 grams per square centimeters
Standard Error 0.004
|
SECONDARY outcome
Timeframe: 1, 6, 18, and 36 monthsPopulation: Subset of patients with measures of biochemical markers
Outcome measures
| Measure |
Teriparatide
n=99 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=100 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
Percent change from baseline at Month 1(N=98,N=99)
|
107.0 percent
Standard Error 13.744
|
-14.8 percent
Standard Error 2.861
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
Percent change from baseline at Month 6(N=86,N=85)
|
130.8 percent
Standard Error 20.752
|
-43.2 percent
Standard Error 3.481
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
Percent change from baseline at Month18(N=77,N=76)
|
86.3 percent
Standard Error 20.231
|
-35.8 percent
Standard Error 4.477
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
Percent change from baseline at Month36(N=59,N=57)
|
61.7 percent
Standard Error 16.156
|
-20.2 percent
Standard Error 10.587
|
SECONDARY outcome
Timeframe: 1, 6, 18, and 36 monthsPopulation: Subset of patients with measures of biochemical markers.
Outcome measures
| Measure |
Teriparatide
n=78 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=89 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
Percent change from baseline at Month18(N=55,N=65)
|
5.1 percent
Standard Error 8.604
|
-21.3 percent
Standard Error 4.207
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
Percent change from baseline at Month36(N=45,N=49)
|
-1.3 percent
Standard Error 7.082
|
-15.4 percent
Standard Error 7.394
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
Percent change from baseline at Month 1(N=66,N=78)
|
48.2 percent
Standard Error 7.024
|
-8.8 percent
Standard Error 2.912
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
Percent change from baseline at Month 6(N=67,N=76)
|
10.5 percent
Standard Error 5.318
|
-22.3 percent
Standard Error 3.694
|
SECONDARY outcome
Timeframe: 1, 6, 18, and 36 monthsPopulation: Subset of patients with measures of biochemical markers
Outcome measures
| Measure |
Teriparatide
n=77 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=89 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
Percent change from baseline at Month 1(N=65,N=78)
|
35.0 percent
Standard Error 7.518
|
0.5 percent
Standard Error 4.897
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
Percent change from baseline at Month 6(N=66,N=76)
|
52.3 percent
Standard Error 10.995
|
-7.2 percent
Standard Error 12.384
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
Percent change from baseline at Month18(N=54,N=65)
|
34.4 percent
Standard Error 9.548
|
-4.1 percent
Standard Error 10.501
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
Percent change from baseline at Month36(N=44,N=49)
|
44.7 percent
Standard Error 14.357
|
20.6 percent
Standard Error 19.912
|
SECONDARY outcome
Timeframe: 1, 6, 18, and 36 monthsPopulation: Subset of patients with measures of biochemical markers
Outcome measures
| Measure |
Teriparatide
n=84 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=91 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
Percent change from baseline at Month 1(N=70,N=79)
|
29.0 percent
Standard Error 8.192
|
-38.6 percent
Standard Error 4.110
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
Percent change from baseline at Month 6(N=66,N=75)
|
66.8 percent
Standard Error 17.143
|
-42.4 percent
Standard Error 5.050
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
Percent change from baseline at Month18(N=64,N=71)
|
29.1 percent
Standard Error 11.714
|
-47.5 percent
Standard Error 6.305
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
Percent change from baseline at Month36(N=49,N=48)
|
30.7 percent
Standard Error 14.205
|
-16.2 percent
Standard Error 23.178
|
SECONDARY outcome
Timeframe: 1, 6, 18, and 36 monthsPopulation: Subset of patients with measures of biochemical markers
Outcome measures
| Measure |
Teriparatide
n=97 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=101 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
Percent change from baseline at Month1(N=94,N=100)
|
147.1 percent
Standard Error 26.408
|
-5.2 percent
Standard Error 3.447
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
Percent change from baseline at Month 6(N=84,N=88)
|
120.0 percent
Standard Error 16.713
|
-33.6 percent
Standard Error 3.656
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
Percent change from baseline at Month18(N=77,N=77)
|
108.9 percent
Standard Error 22.750
|
-25.0 percent
Standard Error 5.118
|
|
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
Percent change from baseline at Month36(N=56,N=58)
|
62.1 percent
Standard Error 20.929
|
-19.6 percent
Standard Error 12.980
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: For vertebral fractures, only those patients with baseline and postbaseline spinal radiographs were included in the analysis.
Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.
Outcome measures
| Measure |
Teriparatide
n=214 Participants
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
n=214 Participants
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Severity-Radiographic Vertebral Fracture: Moderate
|
2 participants
|
2 participants
|
|
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Any Fracture
|
19 participants
|
27 participants
|
|
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Nonvertebral Fracture
|
16 participants
|
15 participants
|
|
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Vertebral Fracture
|
3 participants
|
13 participants
|
|
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Clinical Vertebral Fracture
|
0 participants
|
4 participants
|
|
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Nonvertebral Fragility Fracture
|
9 participants
|
5 participants
|
|
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Severity-Radiographic Vertebral Fracture: Mild
|
1 participants
|
7 participants
|
|
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Severity-Radiographic Vertebral Fracture: Severe
|
0 participants
|
4 participants
|
Adverse Events
Teriparatide
Serious events: 70 serious events
Other events: 190 other events
Deaths: 0 deaths
Alendronate
Serious events: 64 serious events
Other events: 177 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teriparatide
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Surgical and medical procedures
Coronary artery bypass
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Surgical and medical procedures
Hip arthroplasty
|
1.4%
3/214 • Number of events 3
|
0.00%
0/214
|
|
Surgical and medical procedures
Knee arthroplasty
|
1.4%
3/214 • Number of events 4
|
0.47%
1/214 • Number of events 2
|
|
Surgical and medical procedures
Surgery
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Surgical and medical procedures
Vertebroplasty
|
0.00%
0/214
|
0.93%
2/214 • Number of events 2
|
|
Vascular disorders
Arterial insufficiency
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Vascular disorders
Arterial occlusive disease
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Vascular disorders
Deep vein thrombosis
|
0.93%
2/214 • Number of events 2
|
0.47%
1/214 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Vascular disorders
Hypertension
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Vascular disorders
Peripheral vascular disorder
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Vascular disorders
Shock
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Vascular disorders
Venous thrombosis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Blood and lymphatic system disorders
Anaemia
|
0.93%
2/214 • Number of events 2
|
0.47%
1/214 • Number of events 1
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Cardiac disorders
Acute myocardial infarction
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Cardiac disorders
Angina pectoris
|
0.47%
1/214 • Number of events 3
|
0.47%
1/214 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Cardiac disorders
Cardiac arrest
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/214
|
0.93%
2/214 • Number of events 2
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.93%
2/214 • Number of events 2
|
0.93%
2/214 • Number of events 2
|
|
Cardiac disorders
Ventricular fibrillation
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Congenital, familial and genetic disorders
Epidermolysis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Endocrine disorders
Adrenal insufficiency
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Eye disorders
Blindness
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/214
|
0.47%
1/214 • Number of events 2
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Gastrointestinal disorders
Constipation
|
0.93%
2/214 • Number of events 2
|
0.00%
0/214
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.93%
2/214 • Number of events 2
|
0.00%
0/214
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.47%
1/214 • Number of events 1
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Gastrointestinal disorders
Subileus
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
General disorders
Chest pain
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
General disorders
Death
|
0.93%
2/214 • Number of events 2
|
1.9%
4/214 • Number of events 4
|
|
General disorders
Impaired healing
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
General disorders
Multi-organ failure
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
General disorders
Ulcer
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Hepatobiliary disorders
Cholecystitis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.47%
1/214 • Number of events 1
|
0.47%
1/214 • Number of events 1
|
|
Immune system disorders
Antiphospholipid syndrome
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Immune system disorders
Sarcoidosis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Abscess
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Abscess bacterial
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Arthritis bacterial
|
0.47%
1/214 • Number of events 1
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/214
|
0.93%
2/214 • Number of events 6
|
|
Infections and infestations
Cardiac infection
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
1.4%
3/214 • Number of events 3
|
1.4%
3/214 • Number of events 3
|
|
Infections and infestations
Chronic sinusitis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Corneal infection
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Escherichia infection
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/214
|
0.93%
2/214 • Number of events 2
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Gastrointestinal infection
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Herpes zoster
|
0.93%
2/214 • Number of events 2
|
0.00%
0/214
|
|
Infections and infestations
Intervertebral discitis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
0.93%
2/214 • Number of events 2
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Lung abscess
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Lung infection
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Osteomyelitis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Pneumonia
|
3.7%
8/214 • Number of events 8
|
2.8%
6/214 • Number of events 6
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Pneumonia streptococcal
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Respiratory tract infection
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Salmonella sepsis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Sepsis
|
0.93%
2/214 • Number of events 2
|
0.93%
2/214 • Number of events 2
|
|
Infections and infestations
Septic shock
|
0.93%
2/214 • Number of events 2
|
0.93%
2/214 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.93%
2/214 • Number of events 2
|
1.9%
4/214 • Number of events 5
|
|
Infections and infestations
Urosepsis
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Device failure
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
3/214 • Number of events 3
|
1.4%
3/214 • Number of events 3
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.47%
1/214 • Number of events 1
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.47%
1/214 • Number of events 2
|
0.00%
0/214
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.93%
2/214 • Number of events 3
|
0.00%
0/214
|
|
Metabolism and nutrition disorders
Obesity
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.47%
1/214 • Number of events 1
|
0.47%
1/214 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
3/214 • Number of events 3
|
0.93%
2/214 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Nervous system disorders
Sensory disturbance
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Nervous system disorders
Syncope
|
0.47%
1/214 • Number of events 1
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Psychiatric disorders
Delusion
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Renal and urinary disorders
Hydronephrosis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Renal and urinary disorders
Renal failure acute
|
0.93%
2/214 • Number of events 2
|
0.47%
1/214 • Number of events 1
|
|
Renal and urinary disorders
Renal failure chronic
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Reproductive system and breast disorders
Prostatic intraepithelial neoplasia
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.3%
5/214 • Number of events 9
|
0.93%
2/214 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
4/214 • Number of events 4
|
0.93%
2/214 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/214
|
0.47%
1/214 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
3/214 • Number of events 3
|
0.93%
2/214 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.47%
1/214 • Number of events 1
|
0.47%
1/214 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/214
|
0.93%
2/214 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.93%
2/214 • Number of events 2
|
0.93%
2/214 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.47%
1/214 • Number of events 1
|
0.00%
0/214
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
|
Surgical and medical procedures
Arthrodesis
|
0.00%
0/214
|
0.47%
1/214 • Number of events 1
|
Other adverse events
| Measure |
Teriparatide
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
|
Alendronate
Alendronate 10 mg/day oral plus injection placebo, 36 months
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.7%
10/214 • Number of events 10
|
7.5%
16/214 • Number of events 16
|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
11/214 • Number of events 12
|
4.7%
10/214 • Number of events 12
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.4%
18/214 • Number of events 19
|
7.5%
16/214 • Number of events 16
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
9/214 • Number of events 9
|
7.0%
15/214 • Number of events 16
|
|
Gastrointestinal disorders
Gastritis
|
7.0%
15/214 • Number of events 15
|
3.7%
8/214 • Number of events 8
|
|
Gastrointestinal disorders
Nausea
|
16.8%
36/214 • Number of events 44
|
8.4%
18/214 • Number of events 23
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
13/214 • Number of events 13
|
5.1%
11/214 • Number of events 12
|
|
Infections and infestations
Bronchitis
|
9.3%
20/214 • Number of events 32
|
7.9%
17/214 • Number of events 22
|
|
Infections and infestations
Influenza
|
8.4%
18/214 • Number of events 24
|
11.2%
24/214 • Number of events 29
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
7/214 • Number of events 8
|
6.1%
13/214 • Number of events 21
|
|
Infections and infestations
Sinusitis
|
7.0%
15/214 • Number of events 23
|
8.4%
18/214 • Number of events 24
|
|
Infections and infestations
Urinary tract infection
|
9.3%
20/214 • Number of events 27
|
12.1%
26/214 • Number of events 31
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
21/214 • Number of events 26
|
8.9%
19/214 • Number of events 23
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.2%
24/214 • Number of events 25
|
12.1%
26/214 • Number of events 28
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.7%
10/214 • Number of events 12
|
5.6%
12/214 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
7.0%
15/214 • Number of events 15
|
8.4%
18/214 • Number of events 18
|
|
Nervous system disorders
Dizziness
|
7.9%
17/214 • Number of events 20
|
7.0%
15/214 • Number of events 15
|
|
Nervous system disorders
Headache
|
8.4%
18/214 • Number of events 23
|
6.5%
14/214 • Number of events 17
|
|
Psychiatric disorders
Depression
|
8.4%
18/214 • Number of events 19
|
7.5%
16/214 • Number of events 16
|
|
Psychiatric disorders
Insomnia
|
5.6%
12/214 • Number of events 12
|
1.4%
3/214 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
13/214 • Number of events 17
|
1.9%
4/214 • Number of events 6
|
|
Vascular disorders
Hypertension
|
9.8%
21/214 • Number of events 21
|
8.4%
18/214 • Number of events 18
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60