Trial · NCT00697463
Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women
NCT00697463, Phase 2, Phase 3, Completed, Columbia University; results first posted 2018-07-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women. Trials, record NCT00697463. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00697463
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women
- NCT number
- NCT00697463
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 22 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Menopause, Fracture, Osteoporosis
- Interventions
- Teriparatide (PTH 1-34)
- First posted
- 2008-06-13
- Last updated
- 2018-07-26
- Results first posted
- 2018-07-26
- Limitations and caveats
Without an untreated control group, we cannot attribute the observed effects to teriparatide with certainty. The effects of teriparatide on fractures could not be evaluated. Six women received teriparatide for 18 months rather than for 24 months.
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 Density by Dual Energy X-ray Absorptiometry (DXA) | Baseline, Month 18 or 24 reported | Areal BMD at the lumbar spine was measured by dual energy x-ray absorptiometry (DXA) at baseline and at 6, 12, 18, and 24 months, if possible. |
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 Density by Dual Energy X-ray Absorptiometry (DXA) | Baseline, Month 18 or 24 reported | Of 22 women with IOP who enrolled, one withdrew for personal reasons, therefore the overall number of participants analyzed is 21. The percentage of BMD change is calculated for each participant between baseline and Month 24 or between baseline and Month 18, whichever is the longer reported timeframe as some are lost to follow up by Month 24. | percentage of BMD change | MEAN |
Source ClinicalTrials.gov
Results by group1
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 Density by Dual Energy X-ray Absorptiometry (DXA) | Women With Idiopathic Osteoporosis (IOP) | 10.8 | Standard Deviation 8.3 | percentage of BMD change |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Women With Idiopathic Osteoporosis (IOP) | 22 | |
| Overall Study | COMPLETED | Women With Idiopathic Osteoporosis (IOP) | 21 | |
| Overall Study | NOT COMPLETED | Women With Idiopathic Osteoporosis (IOP) | 1 |
Source ClinicalTrials.gov
Adverse events3
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 | Hypercalcemia | Blood and lymphatic system disorders | Women With Idiopathic Osteoporosis (IOP) | 1 | 21 | 1 |
| other | Hypercalciuria | Renal and urinary disorders | Women With Idiopathic Osteoporosis (IOP) | 6 | 21 | 7 |
| other | Distal radius fracture | Musculoskeletal and connective tissue disorders | Women With Idiopathic Osteoporosis (IOP) | 1 | 21 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Women With Idiopathic Osteoporosis (IOP) | 0 | 21 |
| Total, other adverse events | Women With Idiopathic Osteoporosis (IOP) | 8 | 21 |
| Total, serious adverse events | Women With Idiopathic Osteoporosis (IOP) | 0 | 21 |
Source ClinicalTrials.gov
Papers0
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/NCT00697463
GET https://conductscience.org/api/trials/v1/NCT00697463/registered