Overview

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.