NCT00545051

A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

A Randomized, Double-blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-induced Osteoporosis in Post-menopausal Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Placebo	po monthly for 12 months
DRUG	ibandronate	150mg po monthly for 12 months

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2007-10-17
• Last updated: 2016-05-12
• Results posted: 2016-05-12

Locations

15 sites across 1 country: Finland