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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 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 801 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00503113
The ClinicalTrials.gov registry entry for NCT00503113 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 801 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 2 interventions - of which Alendronate is the first listed.
NCT00503113 reports 0 study locations.
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.
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