SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.
Phase 4
Completed
- Conditions
- Post Menopausal Osteoporosis
- Interventions
- Registration Number
- NCT00545480
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 596
Inclusion Criteria
- ambulatory, post-menopausal women who would benefit from bisphosphonate treatment;
- >55 years of age;
- naive to bisphosphonate therapy, or lapsed bisphosphonate users >=6 months.
Exclusion Criteria
- inability to stand or sit in an upright position for at least 60 minutes;
- hypersensitivity to bisphosphonates;
- treatment with other drugs affecting bone 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 persistence to >=10/12 administrations of Bonviva in feedback and no feedback group 12 months
- Secondary Outcome Measures
Name Time Method Differences between groups in persistence 6 months QoL and patient satisfaction 6 and 12 months