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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00545207 |
This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.
Condition | Intervention | Phase |
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Post-Menopausal Osteopenia |
Drug: ibandronate [Bonviva/Boniva] Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-Architecture Parameters in Post-Menopausal Women With Osteopenia |
Estimated Enrollment: | 150 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | March 2010 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 2 years
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2: Placebo Comparator |
Drug: Placebo
po monthly for 2 years
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Ages Eligible for Study: | 55 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
LYON, France, 69000 | |
TOULOUSE, France, 31059 | |
SAINT ETIENNE, France, 42055 | |
PARIS, France, 75010 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML19357 |
Study First Received: | October 16, 2007 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00545207 History of Changes |
Health Authority: | France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS) |
Ibandronic acid Musculoskeletal Diseases Bone Density Conservation Agents |
Bone Diseases, Metabolic Bone Diseases Menopause |
Ibandronic acid Musculoskeletal Diseases Physiological Effects of Drugs Bone Density Conservation Agents |
Bone Diseases, Metabolic Bone Diseases Pharmacologic Actions |