A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)

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

Summary

This 2 arm study will assess the impact of bone marker feedback (BMF), using serum carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on adherence to once monthly ibandronate (150 milligrams [mg] per oral [po]) in women with post-menopausal osteoporosis supported by patient-relationship program (PRP). Participants will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The anticipated time on study treatment is 3-12 months.

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

Details

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

Criteria

Inclusion Criteria:

• ambulatory, post-menopausal women with osteoporosis;

• eligible for bisphosphonate treatment;

• naïve to bisphosphonate therapy, or lapsed users (last bisphosphonate intake greater than or equal to [>=] 6 months ago).

Exclusion Criteria:

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

• inability to swallow a tablet whole;

• hypersensitivity to bisphosphonates;

• treatment with drugs, or presence of active disease, known to influence bone metabolism;

• history of upper gastrointestinal disease.