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NCT00551174 · ClinicalTrials.gov registry record · Phase 4
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 781
- Enrollment target
NCT00551174: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00551174 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 781 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (51% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00551174, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 781 participants
- Enrollment target
Study Summary
This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.
Primary Outcome
Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=\[(measure at time t - measure at baseline)/measure at baseline\]\*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.
Interventions
- DRUG ibandronate [Bonviva/Boniva]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 781 participants |
| Start Date | 2004-10 |
| Est. Completion | 2008-11 |
| Phase | Phase 4 |
What the finished NCT00551174 record still lists
NCT00551174 is an interventional study that assigns participants to a tested intervention. The registered 781 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 (51% higher).
The record links to 0 conditions, and to 1 intervention - of which ibandronate [Bonviva/Boniva] is the first listed.
NCT00551174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00551174 about?
NCT00551174 is a clinical study titled "A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment". This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV ever...
What is the current status of trial NCT00551174?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 781 participants. The study started on 2004-10. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00551174?
The interventions under investigation include: ibandronate [Bonviva/Boniva] (DRUG).
Who is sponsoring clinical trial NCT00551174?
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 NCT00551174's enrollment target sits among peer trials
781 104th of 2000 higher than 1,897 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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