BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ibandronic Acid

Criteria

Inclusion Criteria:

• postmenopausal women or men >30 years of age;

• osteoporosis;

• vertebral osteoporotic fracture in past 4 weeks;

• fracture-related pain requiring analgesic treatment.

Exclusion Criteria:

• non-menopausal women;

• current treatment with another bisphosphonate;

• current treatment with class III analgesics.