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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: GlaxoSmithKline
• Treatments: Diphosphonates; Glucocorticoids; Ibandronic Acid

Criteria

Inclusion Criteria:

• post-menopausal women, 50-85 years of age;

• any inflammatory rheumatoid disease including polymyalgia rheumatica;

• receiving treatment with 5-15 mg/day of prednisolone.

Exclusion Criteria:

• previous treatment with an iv bisphosphonate at any time;

• previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within last year, or >3 months of treatment within last 2 years;

• treatment with parathyroid hormone in last 2 years;

• inability to stand or sit in an upright position for at least 60 minutes;

• inability to swallow a tablet whole;

• history of major gastrointestinal disease.