Conditions: Post-Menopausal Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 801
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva] intervention 3: Alendronate
Intervention descriptions: intervention 1: 3mg intravenous (iv) injection every 3 months intervention 2: 3mg intravenous (iv) infusion every 3 months intervention 3: 70mg per oral (po) weekly

Protocol document: