Efficacy of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and osteoporotic post-menopausal wome

Phase 1

• Conditions: Osteoporotic men and post menopausal osteoporotic women with a fracture of the distal radius; MedDRA version: 14.0Level: LLTClassification code 10031288Term: Osteoporosis with fractureSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2009-014271-41-BE
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-22
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- 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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

- 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;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>- Decreasing the time to the disappearance of fracture line<br><br>To assess the safety of strontium ranelate;Primary end point(s): Time to radiological healing defined as bridging in at least 3 out of 4 cortices of the radius;Timepoint(s) of evaluation of this end point: Time to radiological healing over 24 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Other radiological evaluations.<br>Clinical evaluation (functional test, patient reported outcome).<br>Safety evaluation.;Timepoint(s) of evaluation of this end point: At all post-baseline visits over 24 weeks