At a glance
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A Randomized, Open Label Study Evaluating the Effect on Renal Function of Intravenous Bonviva Given by Injection or Infusion, Compared With Oral Alendronate, in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
In Brief
A Phase 4 clinical trial evaluating ibandronate [Bonviva/Boniva] and Alendronate for Post-Menopausal Osteoporosis. Completed, enrolled 801 participants across 44 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
3mg intravenous (iv) injection every 3 months
3mg intravenous (iv) infusion every 3 months
70mg per oral (po) weekly