Trial · NCT00365456
Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
NCT00365456, Phase 3, Completed, Takeda; results first posted 2012-07-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM). Trials, record NCT00365456. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00365456
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
- NCT number
- NCT00365456
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 407 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Osteoporosis
- Interventions
- Parathyroid Hormone (PTH), Risedronate
- First posted
- 2006-08-17
- Last updated
- 2012-08-20
- Other registries' IDs
- eudract:2005-000730-20
- Results first posted
- 2012-07-20
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 BMD From Start of Trial Period III Until End of Trial Period III. | 12 months | BMD was measured by Dual X-ray Absorptiometry (DXA). |
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 BMD From Start of Trial Period III Until End of Trial Period III. | 12 months | All randomized patients made the Full Analysis Set which was used for the primary and secondary analyses according to intention-to-treat principles. One participant excluded due to missing baseline data at trial period III entry, thus no data could be carried forward for this patient. Missing values imputed by Last Observation Carried Forward. | Percentage Change | LEAST_SQUARES_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 BMD From Start of Trial Period III Until End of Trial Period III. | PTH (1-84) | 1.002 | Standard Error 1.0037 | Percentage Change | |
| Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III. | Risedronate | 0.990 | Standard Error 1.0034 | Percentage Change |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Trial Period I (12 Months) | STARTED | PTH (1-84) | 407 | |
| Trial Period I (12 Months) | STARTED | Risedronate | 0 | |
| Trial Period I (12 Months) | COMPLETED | PTH (1-84) | 282 | |
| Trial Period I (12 Months) | COMPLETED | Risedronate | 0 | |
| Trial Period I (12 Months) | NOT COMPLETED | PTH (1-84) | 125 | |
| Trial Period I (12 Months) | NOT COMPLETED | Risedronate | 0 | |
| Trial Period II (12 Months) | STARTED | PTH (1-84) | 0 | |
| Trial Period II (12 Months) | STARTED | Risedronate | 282 | |
| Trial Period II (12 Months) | COMPLETED | PTH (1-84) | 0 | |
| Trial Period II (12 Months) | COMPLETED | Risedronate | 268 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events156
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 | Vertigo | Ear and labyrinth disorders | PTH (1-84) | 24 | 405 | 26 |
| other | Vertigo | Ear and labyrinth disorders | Risedronate | 0 | 282 | 0 |
| other | Nausea | Gastrointestinal disorders | PTH (1-84) | 98 | 405 | 123 |
| other | Nausea | Gastrointestinal disorders | Risedronate | 0 | 282 | 0 |
| other | Asthenia | General disorders | PTH (1-84) | 23 | 405 | 24 |
| other | Asthenia | General disorders | Risedronate | 0 | 282 | 0 |
| other | Urinary tract infection | Infections and infestations | PTH (1-84) | 23 | 405 | 28 |
| other | Urinary tract infection | Infections and infestations | Risedronate | 14 | 282 | 16 |
| other | Influenza | Infections and infestations | PTH (1-84) | 0 | 405 | 0 |
| other | Influenza | Infections and infestations | Risedronate | 20 | 282 | 24 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PTH (1-84) | ||
| Total, all-cause mortality | Risedronate | ||
| Total, other adverse events | PTH (1-84) | 365 | 405 |
| Total, other adverse events | Risedronate | 95 | 282 |
| Total, serious adverse events | PTH (1-84) | 33 | 405 |
| Total, serious adverse events | Risedronate | 32 | 282 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PTH (1-84) vs Risedronate: serious adverse events |
Source Trial comparisons
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/NCT00365456
GET https://conductscience.org/api/trials/v1/NCT00365456/events?page=2