A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2 g per day of strontium ranelate versus alendronate 70 mg per week in women with postmenopausal osteoporosis on bone geometry and bone strength measured by peripheral-Quantitative Computed Tomography (p-QCT).
- Conditions
- Post-menopausal osteoporosisMedDRA version: 9.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausal
- Registration Number
- EUCTR2007-001509-11-SE
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 148
Inclusion Criteria
- Women of at least 50 years
- Postmenopausal for at least 5 years
- Osteoporosis
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Evolutive cancers during the past 5 years with a risk of bone metastases
- BMI less than 18 or higher than 30 kg/m²
- Severe malabsorption
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effects of strontium ranelate in comparison with alendronate (both treatment with calcium and vitamin D supplement) on the bone geometry and bone strength in postmenopausal osteoporotic women.;Secondary Objective: ;Primary end point(s): Measurement of geometrical and bone strength parameters by pQCT.<br>
- Secondary Outcome Measures
Name Time Method