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NCT00377234 · ClinicalTrials.gov registry record · Phase 4
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 356
- Enrollment target
NCT00377234: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00377234 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 356 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00377234, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 356 participants
- Enrollment target
Study Summary
This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Primary Outcome
Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.
Interventions
- DRUG Risedronate
- DRUG ibandronate [Bonviva/Boniva]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2006-05 |
| Est. Completion | 2008-08 |
| Phase | Phase 4 |
What the finished NCT00377234 record still lists
NCT00377234 is an interventional study that assigns participants to a tested intervention. The registered 356 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 (31% lower).
The record links to 0 conditions, and to 2 interventions - of which Risedronate is the first listed.
NCT00377234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00377234 about?
NCT00377234 is a clinical study titled "A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.". This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then c...
What is the current status of trial NCT00377234?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 356 participants. The study started on 2006-05. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00377234?
The interventions under investigation include: Risedronate (DRUG), ibandronate [Bonviva/Boniva] (DRUG).
Who is sponsoring clinical trial NCT00377234?
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 NCT00377234's enrollment target sits among peer trials
356 228th of 2000 higher than 1,773 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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