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

• 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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-12
• Last Update Posted: 15 April 2013

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