NCT00503113

A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 801 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-Menopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	ibandronate [Bonviva/Boniva]	3mg intravenous (iv) injection every 3 months
DRUG	ibandronate [Bonviva/Boniva]	3mg intravenous (iv) infusion every 3 months
DRUG	Alendronate	70mg per oral (po) weekly

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2007-07-18
• Last updated: 2011-06-17
• Results posted: 2011-06-17

Locations

44 sites across 6 countries: United States, Argentina, Brazil, Mexico, South Africa, Switzerland