PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.

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

Details

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

Criteria

Inclusion Criteria:

• Women with postmenopausal osteoporosis or osteopenia

• Discontinuation of daily and /or weekly alendronate or risedronate therapy because of GI intolerance (eg, heartburn, acid reflux, stomach upset)

Exclusion Criteria:

• Inability to stand or sit upright for 60 minutes

• Inability to swallow a tablet whole - Hypersensitivity to any component of Boniva

• Malignant disease diagnosed within previous 10 years (except resected basal cell cancer); contraindications for calcium or vitamin D therapy

• Patients who do not fulfill a minimum 3 months wash-out therapy from any previous bisphosphonate therapy