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

Roche

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: ibandronate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545051

ML20088

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: Female

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups, including a placebo group

Ibandronate

Experimental group

Description:

Participants received monthly oral ibandronate (150 milligrams \[mg\]) for 12 months.

Treatment:

Drug: ibandronate

Placebo

Placebo Comparator group

Description:

Participants received monthly oral placebo for 12 months.

Treatment:

Drug: Placebo