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NCT00402441 · ClinicalTrials.gov registry record · Phase 4
Risedronate in the Prevention of Osteoporosis in Postmenopausal Women
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 260
- Enrollment target
NCT00402441: Completed Phase 4 study, sponsored by Sanofi.
NCT00402441 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 260 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00402441, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 260 participants
- Enrollment target
Study Summary
Primary Objective: * To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal. Secondary objectives: * To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining total proximal femur, femoral neck, and trochanter BMD after 1 year of treatment in women who are 0.5-5 years postmenopausal * To assess the general safety of 35-mg risedronate administered once weekly.
Interventions
- DRUG Risedronate (HMR4003)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2002-09 |
| Est. Completion | 2004-06 |
| Phase | Phase 4 |
What the finished NCT00402441 record still lists
NCT00402441 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Risedronate (HMR4003) is the first listed.
NCT00402441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00402441 about?
NCT00402441 is a clinical study titled "Risedronate in the Prevention of Osteoporosis in Postmenopausal Women". Primary Objective: * To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal. Secondary objectives: * T...
What is the current status of trial NCT00402441?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 260 participants. The study started on 2002-09. Estimated completion is 2004-06.
What interventions are being tested in trial NCT00402441?
The interventions under investigation include: Risedronate (HMR4003) (DRUG).
Who is sponsoring clinical trial NCT00402441?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00402441's enrollment target sits among peer trials
260 326th of 2000 higher than 1,670 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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