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NCT00048074 · ClinicalTrials.gov registry record · Phase 3
DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,395
- Enrollment target
NCT00048074: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00048074 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,395 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00048074, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,395 participants
- Enrollment target
Study Summary
This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. 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
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)
Interventions
- DRUG ibandronate [Bonviva/Boniva]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,395 participants |
| Start Date | 2002-06 |
| Est. Completion | 2005-05 |
| Phase | Phase 3 |
What the finished NCT00048074 record still lists
NCT00048074 is an interventional study that assigns participants to a tested intervention. Its 1,395 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% higher).
The record links to 0 conditions, and to 1 intervention - of which ibandronate [Bonviva/Boniva] is the first listed.
NCT00048074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00048074 about?
NCT00048074 is a clinical study titled "DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis". This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is ...
What is the current status of trial NCT00048074?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,395 participants. The study started on 2002-06. Estimated completion is 2005-05.
What interventions are being tested in trial NCT00048074?
The interventions under investigation include: ibandronate [Bonviva/Boniva] (DRUG).
Who is sponsoring clinical trial NCT00048074?
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 NCT00048074's enrollment target sits among peer trials
1,395 176th of 2000 higher than 1,825 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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