A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2g per day of strontium ranelate versus alendronate 70mg per week in women with postmenopausal osteoporosis on bone microarchitecture measured by high resolution peripheral-Quantitative Computed Tomography (p-QCT).
- Conditions
- Treatment of postmenopausal Osteoporosis to reduce the risk of hip and vertebral fracturesMedDRA version: 8.1Level: PTClassification code 10031290Term: Osteoporotic fracture
- Registration Number
- EUCTR2006-002732-22-DE
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 72
Inclusion Criteria
. Women of at least 50 years old
. Postmenopausal for at least 5 years
. Diagnosis of 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
. Use of forbidden previous and concomitant treatment interfering with bone metabolism
. Evolutive cancers during the past 5 years with a risk of bone metastases
. BMI <18 or >30 kg/m2
. Severe malabsorption
. Skeletal disease
. Significant and evolutive hyperthyroidism
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method