Osteoporosis Prevention With Low Dose Alendronate
Phase 3
Completed
- Conditions
- Osteopenia
- Interventions
- Registration Number
- NCT00463268
- Lead Sponsor
- University Hospital of Mont-Godinne
- Brief Summary
The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 83
Inclusion Criteria
- 45 to 60 year-old women
- Menopausal since at least 6 months
- Baseline lumbar BMD from -1 till -2.5
Exclusion Criteria
- Bone disease other than osteopenia
- Treatment with selective estrogen receptor modulator (SERMs), calcitonin or hormone replacement therapy within 6 monts prior to randomization
- Former or current treatment with any bisphosphonate or bone forming agents
- Chronic use of oral or iv corticosteroids
- Any diagnosis of malignancy less than 12 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Calcium/Vitamin D Alendronate 70 mg every 2 weeks 2 Calcium/Vitamin D Alendronate 70 mg placebo tablet every 2 weeks 2 placebo Alendronate 70 mg placebo tablet every 2 weeks 1 alendronate Alendronate 70 mg every 2 weeks
- Primary Outcome Measures
Name Time Method percentage of lumbar BMD modification after 2 years 2 years
- Secondary Outcome Measures
Name Time Method percentage of hip BMD modification (total hip and sub-regions) 2 years percentage of modification of bone remodeling markers 2 years
Trial Locations
- Locations (1)
University (UCL) Louvain Hospital in Mont-Godinne
🇧🇪Yvoir, Namur, Belgium