Clinical Trial: BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomised, Open Label Study to Investigate the Impact of Bone Marker Feedback at 2 Months on Adherence to Monthly Oral Bonviva (Ibandronate) in Women With Post-menopausal Oste
Brief Summary: This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group [ Time Frame: 6 months ]
Original Primary Outcome: Comparison of the proportion of patients with >=83% adherence at 6 months (ie 5 of 6 possible administrations)to Bonviva in the feedback vs no feedback group.
Current Secondary Outcome:
- Patient satisfaction by OPSAT-Q and OPPS. [ Time Frame: 6 months ]
- Tolerability; SAEs. [ Time Frame: Throughout study ]
Original Secondary Outcome: Compliance: Patient satisfaction at 6 months by OPSAT-Q and OPPS. Safety: Tolerability, SAEs
Information By: Hoffmann-La Roche
Dates:
Date Received: October 16, 2007
Date Started: March 2006
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016
