A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.
Phase 3
Completed
- Conditions
- Post-Menopausal Osteopenia
- Interventions
- Drug: Placebo
- Registration Number
- NCT00545207
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
Inclusion Criteria
- post-menopausal women, aged 55-75 years;
- diagnosed osteopenia.
Exclusion Criteria
- history of osteoporotic vertebral fracture;
- contraindication to ibandronate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ibandronate [Bonviva/Boniva] - 2 Placebo -
- Primary Outcome Measures
Name Time Method Trabecular BV/TV at distal radius of non-dominant arm 12 arms
- Secondary Outcome Measures
Name Time Method Lumbar hip and wrist BMD 1 and 2 years Serum CTX Intervals throughout study Trabecular BV/TV at distal radius of non-dominant arm 6 months and 2 years AEs and laboratory parameters Throughout study Bone density, trabecular BV/TV at distal tibia 6 months, 1 and 2 years