A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Diphosphonates; Etidronic Acid; Ibandronic Acid; Risedronate Sodium; Risedronic Acid

Criteria

Inclusion Criteria:

• ambulatory women with post-menopausal osteoporosis;

• patients who are bisphosphonate-naive, or who have previously received oral daily or i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).

Exclusion Criteria:

• malignant disease diagnosed within previous 10 years (except for successfully resected basal cell cancer;) breast cancer within previous 20 years;

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

• disease/disorder/treatment with drugs known to influence bone metabolism.