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NCT00358176 · ClinicalTrials.gov registry record · Phase 3
Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,231
- Enrollment target
NCT00358176: Completed Phase 3 study, sponsored by Sanofi.
NCT00358176 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,231 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00358176, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,231 participants
- Enrollment target
Study Summary
To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis. To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption. To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.
Interventions
- DRUG Risedronate (HMR4003)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,231 participants |
| Start Date | 2004-07 |
| Est. Completion | 2007-03 |
| Phase | Phase 3 |
What the finished NCT00358176 record still lists
NCT00358176 is an interventional study that assigns participants to a tested intervention. Its 1,231 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% higher).
The record links to 0 conditions, and to 1 intervention - of which Risedronate (HMR4003) is the first listed.
NCT00358176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00358176 about?
NCT00358176 is a clinical study titled "Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women". To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis. To confirm the efficacy of 75 mg risedronate tablets taken on 2 co...
What is the current status of trial NCT00358176?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,231 participants. The study started on 2004-07. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00358176?
The interventions under investigation include: Risedronate (HMR4003) (DRUG).
Who is sponsoring clinical trial NCT00358176?
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 NCT00358176's enrollment target sits among peer trials
1,231 214th of 2000 higher than 1,787 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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