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 fracture of the distal radiusMedDRA version: 12.1 Level: LLT Classification code 10031288 Term: Osteoporosis with fracture
- Registration Number
- EUCTR2009-014271-41-GB
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- 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 lesions and/or fractures in other anatomical regions
- Known skeletal disease
- Displaced fracture
- Fracture 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 insufficiency or renal insufficiency
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the efficacy of S12911 versus placebo in accelerating radiological healing of distal radius fractures as defined by the bridging in at least 3 out of 4 cortices;<br> Secondary Objective: To demonstrate the efficacy of strontium ranelate in<br> - Enhancing clinical healing<br> - Enhancing early healing<br> - Decreasing the rate of delayed healing<br> - Decreasing the rate of secondary reduction of the fracture<br> - Accelerating radiological healing of distal radius fractures as defined by the bridging in at least 1, 2 and 4 out of 4 cortices<br><br> To assess the safety of strontium ranelate<br> ;Primary end point(s): Time to radiological healing defined as bridging in at least 3 out of 4 cortices of the radius
- Secondary Outcome Measures
Name Time Method