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NCT00397839 · ClinicalTrials.gov registry record · Phase 3
The Effect Of Oral Ibandronate In Male Osteoporosis
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 135
- Enrollment target
NCT00397839: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00397839 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 135 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00397839, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 135 participants
- Enrollment target
Study Summary
Male osteoporosis is a common and important clinical problem, associated with significant morbidity, mortality and societal expense. Approximately 10% of men =65 years of age are osteoporotic. The proposed study will evaluate efficacy and safety of oral ibandronate given 150 mg once-monthly for 12 months versus placebo in men with primary osteoporosis. Less frequent, once monthly, dosing is expected to improve patient's treatment adherence compared to a weekly dosing regimen.
Primary Outcome
BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
Interventions
- DRUG placebo
- DRUG Ibandronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00397839 record still lists
NCT00397839 is an interventional study that assigns participants to a tested intervention. The registered 135 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 (83% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00397839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00397839 about?
NCT00397839 is a clinical study titled "The Effect Of Oral Ibandronate In Male Osteoporosis". Male osteoporosis is a common and important clinical problem, associated with significant morbidity, mortality and societal expense. Approximately 10% of men =65 years of age are osteoporotic. The proposed study will evaluate efficacy and safety of oral ibandronate given 150 mg once-monthly for 12 m...
What is the current status of trial NCT00397839?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2007-01. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00397839?
The interventions under investigation include: placebo (DRUG), Ibandronate (DRUG).
Who is sponsoring clinical trial NCT00397839?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00397839's enrollment target sits among peer trials
135 1582nd of 2000 higher than 416 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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