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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00545909 |
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.
Condition | Intervention | Phase |
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Post-Menopausal Osteoporosis |
Drug: ibandronate [Bonviva/Boniva] |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 Osteoporosis. |
Enrollment: | 585 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (+ feedback)
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2: Active Comparator |
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (- feedback)
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Ages Eligible for Study: | 55 Years to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML19913 |
Study First Received: | October 16, 2007 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00545909 |
Health Authority: | Belgium: Agence federale des medicaments at des produits de sante |
Ibandronic acid Musculoskeletal Diseases Osteoporosis, Postmenopausal Osteoporosis |
Bone Diseases, Metabolic Bone Diseases Menopause |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |