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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 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 719 participants.
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.
Interventions
- DRUG ibandronate [Bonviva/Boniva]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 719 participants |
| Start Date | 2004-05 |
| Est. Completion | 2008-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00081653
The ClinicalTrials.gov registry entry for NCT00081653 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 719 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ibandronate [Bonviva/Boniva] is the first listed.
NCT00081653 reports 0 study locations.
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.
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