A multicenter, prospective, randomized, double-blind, placebo-controlled, international study to assess the effects of 2g per day of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and women. - The fracture healing study
- Conditions
- Osteoporotic men and post menopausal osteoporotic women with a fracure of the distal radiusMedDRA version: 9.1Level: LLTClassification code 10031288
- Registration Number
- EUCTR2009-014271-41-IT
- Lead Sponsor
- INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Men or postmenopausal women, aged >=50 years - Osteoporotic patient with a fracture of the distal radius (Colles` fracture).
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
Multiple trauma with serious lesion and/or fractures in another anatomical region - Known skeletal disease - Displaced fracture - Fracure requiring surgical intervention - Associated fracture of the ulnar shaft - Fracture of the dorsal/volar margin (Barton or reverse Barton fracture) - Volar angulation -(Smith fracture or reverse Colles` fracture) - Vertical fracture and/or fracture of the radial styloid - History or increased risk of venous thrombo-embolism - Known liver insuffuciency ir renal insufficiency.
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