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NCT00081653 · ClinicalTrials.gov registry record · Phase 4
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 719
- Enrollment target
NCT00081653: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00081653 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 719 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (39% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00081653, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 719 participants
- Enrollment target
Study Summary
This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
Primary Outcome
Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm\^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).
Interventions
- DRUG ibandronate [Bonviva/Boniva]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 719 participants |
| Start Date | 2004-05 |
| Est. Completion | 2008-05 |
| Phase | Phase 4 |
What the finished NCT00081653 record still lists
NCT00081653 is an interventional study that assigns participants to a tested intervention. The registered 719 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (39% higher).
The record links to 0 conditions, and to 1 intervention - of which ibandronate [Bonviva/Boniva] is the first listed.
NCT00081653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00081653 about?
NCT00081653 is a clinical study titled "A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva". This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Pati...
What is the current status of trial NCT00081653?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 719 participants. The study started on 2004-05. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00081653?
The interventions under investigation include: ibandronate [Bonviva/Boniva] (DRUG).
Who is sponsoring clinical trial NCT00081653?
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 NCT00081653's enrollment target sits among peer trials
719 114th of 2000 higher than 1,887 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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