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NCT00503113 · ClinicalTrials.gov registry record · Phase 4
A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 801
- Enrollment target
NCT00503113: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00503113 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 801 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00503113, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 801 participants
- Enrollment target
Study Summary
This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Primary Outcome
The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment.
Interventions
- DRUG Alendronate
- DRUG ibandronate [Bonviva/Boniva]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 801 participants |
| Start Date | 2007-07 |
| Est. Completion | 2010-04 |
| Phase | Phase 4 |
What the finished NCT00503113 record still lists
NCT00503113 is an interventional study that assigns participants to a tested intervention. The registered 801 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 (55% higher).
The record links to 0 conditions, and to 2 interventions - of which Alendronate is the first listed.
NCT00503113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00503113 about?
NCT00503113 is a clinical study titled "A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.". This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv...
What is the current status of trial NCT00503113?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 801 participants. The study started on 2007-07. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00503113?
The interventions under investigation include: Alendronate (DRUG), ibandronate [Bonviva/Boniva] (DRUG).
Who is sponsoring clinical trial NCT00503113?
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 NCT00503113's enrollment target sits among peer trials
801 98th of 2000 higher than 1,902 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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