Trial · NCT01440803
Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women
NCT01440803, Phase 2, Completed, Elizabeth Shane; results first posted 2019-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women. Trials, record NCT01440803. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01440803
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women
- NCT number
- NCT01440803
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Elizabeth Shane
- Conditions
- Adult Idiopathic Generalized Osteoporosis
- Interventions
- Teriparatide, Saline Placebo
- First posted
- 2011-09-27
- Last updated
- 2019-12-11
- Results first posted
- 2019-05-09
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Lumbar Spine Bone Mineral Density (LS-BMD) on Active Medication | Baseline and 12 months | Dual Energy X-ray Absorptiometry (DXA) will be used to measuring bone mineral density (BMD). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Lumbar Spine Bone Mineral Density (LS-BMD) on Active Medication | Baseline and 12 months | One patient in the Teriparatide (Forteo) arm was lost to follow up before the completion of the 12 month visit, therefore could not be analyzed for the primary outcome. | percentage of change | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Lumbar Spine Bone Mineral Density (LS-BMD) on Active Medication | Teriparatide (Forteo) | 10.1 | Standard Deviation 5.4 | percentage of change | |
| Change in Lumbar Spine Bone Mineral Density (LS-BMD) on Active Medication | Placebo Saline Injection | 4.1 | Standard Deviation 6.5 | percentage of change |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Saline Injection | 13 | |
| Overall Study | STARTED | Teriparatide (Forteo) | 28 | |
| Overall Study | Period 1 - Forteo/Placebo | Placebo Saline Injection | 13 | |
| Overall Study | Period 1 - Forteo/Placebo | Teriparatide (Forteo) | 28 | |
| Overall Study | Period 2 - Forteo/Forteo | Placebo Saline Injection | 13 | |
| Overall Study | Period 2 - Forteo/Forteo | Teriparatide (Forteo) | 28 | |
| Overall Study | Period 3 - Forteo Open Label | Placebo Saline Injection | 13 | |
| Overall Study | Period 3 - Forteo Open Label | Teriparatide (Forteo) | 27 | |
| Overall Study | COMPLETED | Placebo Saline Injection | 11 | |
| Overall Study | COMPLETED | Teriparatide (Forteo) | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriparatide (Forteo) (24 Months) | 0 | 28 |
| Total, all-cause mortality | Placebo Saline Injection (6 Months) | 0 | 13 |
| Total, all-cause mortality | Placebo Saline Injection (6-24 Months) | 0 | 13 |
| Total, other adverse events | Teriparatide (Forteo) (24 Months) | 0 | 28 |
| Total, other adverse events | Placebo Saline Injection (6 Months) | 0 | 13 |
| Total, other adverse events | Placebo Saline Injection (6-24 Months) | 0 | 13 |
| Total, serious adverse events | Teriparatide (Forteo) (24 Months) | 0 | 28 |
| Total, serious adverse events | Placebo Saline Injection (6 Months) | 0 | 13 |
| Total, serious adverse events | Placebo Saline Injection (6-24 Months) | 0 | 13 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD003902 | Teriparatide for Idiopathic Osteoporosis in Premenopausal Women: A Phase 2 Study | SHANE, ELIZABETH J; COHEN, ADI | COLUMBIA UNIVERSITY HEALTH SCIENCES | FOOD AND DRUG ADMINISTRATION | 2011 to 2019 |
Source NIH RePORTER
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/NCT01440803
GET https://conductscience.org/api/trials/v1/NCT01440803/registered