A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.

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

Details

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

Criteria

Inclusion Criteria:

• Women newly diagnosed with postmenopausal osteoporosis

• Naive to prior bisphosphonate therapy

Exclusion Criteria:

• Inability to stand or sit upright for at least 60 minutes

• Inability to swallow a tablet whole

• Hypersensitivity to any component of ibandronate

• Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months

• Other osteoporosis drug within last 3 months

• Malignant disease diagnosed within previous 10 years, except resected basal cell cancer