Efficacy of strontium ranelate in the management of long bone fractures in osteoporotic patients
- Conditions
- ower long bone fractureMusculoskeletal DiseasesLimb fracture, osteoporosis
- Registration Number
- ISRCTN60251236
- Lead Sponsor
- Institut de Recherches Internationales Servier (France)
- Brief Summary
2013 abstract from ACR/ARHP Annual Meeting on: http://acrabstracts.org/abstract/efficacy-of-a-6-month-treatment-with-strontium-ranelate-2gday-in-the-improvement-of-long-bone-fractures-with-delayed-union-or-non-union/
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
30/11/2012: Current inclusion criteria as of 01/09/2011:
1. Men aged > 18 years and postmenopausal women menopause >2 years
2. Patient with long bone fracture with a delayed union or a non-union
As of 27/07/11:
1. Osteoporotic men and osteoporotic postmenopausal women.
2. Patient with a fracture of limb with a delayed union or a non-union
As of 09/07/10:
1. Osteoporotic men and osteoporotic postmenopausal women
2. Patient with a fracture of the lower limbs with a delayed union or a non-union
1. Fractures not meeting inclusion criteria (including pathological fractures)
2. Bone-related disease other than osteoporosis
3. Concomittant treatments interfering with bone metabolism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Radiological union of the fracture, performed every 2 or 3 months during the study<br> 2. Clinical assessments (including pain, quality of life, mobility, etc.), performed every 2 or 3 months during the study (mobility test performed every 6 months)<br> 3. Safety evaluations, performed every 2 or 3 months during the study<br>
- Secondary Outcome Measures
Name Time Method o secondary outcome measures