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

Phase 4

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: ibandronate [Bonviva/Boniva]

• Registration Number: NCT00545909
• Lead Sponsor: Hoffmann-La Roche

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 Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 585

Inclusion Criteria

• ambulatory post-menopausal women with osteoporosis;
• 55-85 years of age;
• eligible for bisphosphonate treatment;
• naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake > 6 months ago).

Exclusion Criteria

• inability to stand or sit in an upright position for at least 60 minutes;
• inability to swallow a tablet whole;
• hypersensitivity to bisphosphonates;
• administration of any drug, or presence of active disease, known to influence bone metabolism;
• uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism;
• history of major upper gastrointestinal disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ibandronate [Bonviva/Boniva]	-
2	ibandronate [Bonviva/Boniva]	-

Primary Outcome Measures

Name	Time	Method
Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group	6 months

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction by OPSAT-Q and OPPS.	6 months
Tolerability; SAEs.	Throughout study