NCT00545363

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

A Randomized Open-Label Study to Investigate the Impact of Bone Marker Feedback at 3 Months on Adherence to Monthly Oral Bonviva in Women With Post-Menopausal Osteoporosis Supported by a Patient Relationship Program

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 716 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Ibandronate	Participants will receive ibandronate 150 mg QM orally for 6 months.

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-10-17
• Last updated: 2016-10-24
• Results posted: 2016-10-24

Locations

52 sites across 7 countries: Hungary, Latvia, Poland, Romania, Russia, Slovakia, Slovenia