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

Phase 3

Completed

• Conditions: Radius fracture, Osteoporosis; Musculoskeletal Diseases; Osteoporosis with pathological fracture

• Registration Number: ISRCTN51868986
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-05
• Study Completion: 2012-03-31
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

1. Osteoporotic men and osteoporotic post-menopausal women
2. Aged superior or equal to 50 years
3. Patient with a fracture of the distal radius (Colles' fracture)

Exclusion Criteria

1. Fractures not meeting inclusion criteria (including displaced radius fractures)
2. Concomitant treatments likely to interfere with bone metabolism

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to radiological healing. Radiological evaluation will be performed at baseline, at week 4, 6, 7, 8, 9, 10, 12, 14 and at the last study visit. No radiography will be performed once radiological healing is complete, except at the last study visit.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Other radiological evaluations, performed at baseline, at week 4, 6, 7, 8, 9, 10, 12, 14 and at the last study visit. No radiography will be performed once radiological healing is complete, except at the last study visit.<br> 2. Clinical evaluation (including mobility, quality of life, etc), performed at least once every 4 weeks from baseline to week 18 and at the last study visit<br> 3. Safety evaluation, performed at least once every 4 weeks from baseline to week 18 and at the last study visit<br>