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NCT00619957 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
A Phase 3 study, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 285
- Enrollment target
NCT00619957: Completed Phase 3 study, sponsored by Warner Chilcott.
NCT00619957 is a Phase 3 study that has completed, run by Warner Chilcott. The registered enrollment target is 285 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00619957, a Phase 3 study, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 285 participants
- Enrollment target
Study Summary
Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.
Primary Outcome
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Interventions
- DRUG Placebo tablet
- DRUG Risedronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2002-06 |
| Est. Completion | 2007-05 |
| Phase | Phase 3 |
What the finished NCT00619957 record still lists
NCT00619957 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo tablet is the first listed.
NCT00619957 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00619957 about?
NCT00619957 is a clinical study titled "Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis". Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.
What is the current status of trial NCT00619957?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 285 participants. The study started on 2002-06. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00619957?
The interventions under investigation include: Placebo tablet (DRUG), Risedronate (DRUG).
Who is sponsoring clinical trial NCT00619957?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00619957's enrollment target sits among peer trials
285 1185th of 2000 higher than 812 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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