Prevention of Postmenopausal Bone Loss in Osteopenic Women with Alendronate given on a 70 mg Once-every two week Regimen : a 2-year, Double-blind, Placebo-controlled Clinical Trial
- Conditions
- osteopenia and postmenopausal patient
- Registration Number
- EUCTR2006-005862-38-BE
- Lead Sponsor
- CL Mont Godinne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 150
Inclusion Criteria
- female aged 45-60 years,
- post menopausal for at least 6 months,
- BMD between -1 and -2.5 T-scores,
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- former treatment susceptible of modifying the bone metabolism
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as bone loss prevention for menopausal, osteopenic patients, who don't want or can't receive an estrogenic substitution treatment<br> ;Secondary Objective: primary endpoint : % of lumbar BMD modification after 2 years<br><br>secondary endpoint : % of hip BMD modification, % modification of bone remodeling markers;Primary end point(s): % of lumbar BMD modification after 2 years<br>
- Secondary Outcome Measures
Name Time Method