NCT00545909

BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis

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 Osteoporosis.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 585 (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 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.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	ibandronate [Bonviva/Boniva]	150mg po monthly for 6 months (+ feedback)
DRUG	ibandronate [Bonviva/Boniva]	150mg po monthly for 6 months (- feedback)

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2007-10-17
• Last updated: 2016-11-02

Locations

57 sites across 5 countries: Austria, Belgium, Greece, Ireland, Luxembourg