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NCT00129623 · ClinicalTrials.gov registry record · Phase 4
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 160
- Enrollment target
NCT00129623: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00129623 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 160 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00129623, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 160 participants
- Enrollment target
Study Summary
This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Primary Outcome
BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The change in BMD was defined as the relative difference between the last individual measuremen
Interventions
- DRUG Placebo
- DRUG ibandronate [Bonviva/Boniva]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2005-12 |
| Est. Completion | 2007-12 |
| Phase | Phase 4 |
What the finished NCT00129623 record still lists
NCT00129623 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00129623 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00129623 about?
NCT00129623 is a clinical study titled "A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia". This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, ...
What is the current status of trial NCT00129623?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 160 participants. The study started on 2005-12. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00129623?
The interventions under investigation include: Placebo (DRUG), ibandronate [Bonviva/Boniva] (DRUG).
Who is sponsoring clinical trial NCT00129623?
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 NCT00129623's enrollment target sits among peer trials
160 507th of 2000 higher than 1,485 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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