A double-blind, multicentre, international randomised study to assess the effects of 6 months or 12 months administration of strontium ranelate versus biphosphonates on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis
Not Applicable
Completed
- Conditions
- Postmenopausal osteoporosis in womenMusculoskeletal DiseasesOsteoporosis
- Registration Number
- ISRCTN50493318
- Lead Sponsor
- Institut de Recherches Internationales Servier (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 387
Inclusion Criteria
1. Women of at least 50 years of age
2. Postmenopausal for at least three years
3. Osteoporosis
Exclusion Criteria
1. Any medical or anatomical condition that potentially could put the patient at additional risk of an adverse event due to the biopsy procedure or that potentially could lead to an impossibility to perform a transiliac bone biopsy on each side
2. Previous and concomitant treatments interfering with bone metabolism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Histomorphometry on paired transiliac biopsies performed at baseline and after treatment (cancellous mineralising surfaces).
- Secondary Outcome Measures
Name Time Method <br> 1. Other histomorphometric parameters<br> 2. Bone markers<br>