Trial · NCT00414973
A Study for Patients With Osteoporosis
NCT00414973, Phase 3, Completed, Eli Lilly and Company; results first posted 2009-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study for Patients With Osteoporosis. Trials, record NCT00414973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00414973
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for Patients With Osteoporosis
- NCT number
- NCT00414973
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 364 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Osteoporosis
- Interventions
- Teriparatide, Salmon Calcitonin
- First posted
- 2006-12-22
- Last updated
- 2009-10-28
- Results first posted
- 2009-08-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women | Baseline to 24 weeks | Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. |
| Secondary | Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women | Baseline to 24 weeks | Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. |
| Secondary | Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women | Baseline to 12 weeks and 24 weeks | Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline. |
| Secondary | Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men | Baseline to 24 weeks | Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. |
| Secondary | Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men | Baseline to 24 weeks | Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. |
| Secondary | Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men | Baseline to 12 weeks and 24 weeks | Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women | Baseline to 24 weeks | Number of Intention to Treat patients with baseline and at least one post baseline measurement. Last Observation Carried Forward. | percentage change in lumbar spine BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women | Baseline to 24 weeks | Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward. | percentage change in total hip BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women | Baseline to 12 weeks and 24 weeks | Number of Intention to Treat patients with measurements at respective visits. | percentage change in osteocalcin | MEDIAN |
| SECONDARY | Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men | Baseline to 24 weeks | Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward. | percentage change in lumbar spine BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men | Baseline to 24 weeks | Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward. | percentage change in total hip BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men | Baseline to 12 weeks and 24 weeks | Number of Intention to Treat patients with measurements at respective visit. | percentage change in osteocalcin | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women | Teriparatide - Females | 6.04 | Standard Error 0.48 | percentage change in lumbar spine BMD | |
| Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women | Calcitonin - Females | 1.65 | Standard Error 0.65 | percentage change in lumbar spine BMD | |
| Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women | Teriparatide - Females | -0.53 | Standard Error 0.44 | percentage change in total hip BMD | |
| Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women | Calcitonin - Females | -0.62 | Standard Error 0.59 | percentage change in total hip BMD | |
| Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women | Teriparatide - Females | Week 12 Percentage Change (n=202, n=102) | 113.87 | Inter-Quartile Range 21.46 | percentage change in osteocalcin |
| Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women | Calcitonin - Females | Week 12 Percentage Change (n=202, n=102) | -7.67 | Inter-Quartile Range 5.43 | percentage change in osteocalcin |
| Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women | Teriparatide - Females | Week 24 Percentage Change (n=191, n=97) | 137.45 | Inter-Quartile Range 36.53 | percentage change in osteocalcin |
| Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women | Calcitonin - Females | Week 24 Percentage Change (n=191, n=97) | -10.58 | Inter-Quartile Range 8.21 | percentage change in osteocalcin |
| Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men | Teriparatide - Males | 6.01 | Standard Error 1.20 | percentage change in lumbar spine BMD | |
| Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men | Calcitonin - Males | 3.38 | Standard Error 1.77 | percentage change in lumbar spine BMD |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teriparatide - Females | 218 | |
| Overall Study | STARTED | Calcitonin - Females | 109 | |
| Overall Study | STARTED | Teriparatide - Males | 24 | |
| Overall Study | STARTED | Calcitonin - Males | 11 | |
| Overall Study | COMPLETED | Teriparatide - Females | 190 | |
| Overall Study | COMPLETED | Calcitonin - Females | 99 | |
| Overall Study | COMPLETED | Teriparatide - Males | 21 | |
| Overall Study | COMPLETED | Calcitonin - Males | 11 | |
| Overall Study | NOT COMPLETED | Teriparatide - Females | 28 | |
| Overall Study | NOT COMPLETED | Calcitonin - Females | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events140
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Teriparatide - Females | 6 | 217 | 8 |
| other | Palpitations | Cardiac disorders | Calcitonin - Females | 1 | 110 | 1 |
| other | Palpitations | Cardiac disorders | Teriparatide - Males | 0 | 24 | 0 |
| other | Palpitations | Cardiac disorders | Calcitonin - Males | 0 | 11 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Teriparatide - Females | 2 | 217 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Calcitonin - Females | 2 | 110 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Teriparatide - Males | 1 | 24 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Calcitonin - Males | 0 | 11 | 0 |
| other | Nausea | Gastrointestinal disorders | Teriparatide - Females | 11 | 217 | 15 |
| other | Nausea | Gastrointestinal disorders | Calcitonin - Females | 0 | 110 | 0 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriparatide - Females | ||
| Total, all-cause mortality | Calcitonin - Females | ||
| Total, all-cause mortality | Teriparatide - Males | ||
| Total, all-cause mortality | Calcitonin - Males | ||
| Total, other adverse events | Teriparatide - Females | 67 | |
| Total, other adverse events | Calcitonin - Females | 26 | |
| Total, other adverse events | Teriparatide - Males | 7 | |
| Total, other adverse events | Calcitonin - Males | 0 | |
| Total, serious adverse events | Teriparatide - Females | 8 | |
| Total, serious adverse events | Calcitonin - Females | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00414973
GET https://conductscience.org/api/trials/v1/NCT00414973/events?page=2