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

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.

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.