Effect of treatment with L0006CP on the time of fracture-healing

Not Applicable

Completed

• Conditions: Wrist fracture; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN71678602
• Lead Sponsor: Pierre Fabre (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-07
• Study Completion: 2011-10-15
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Male or menopausal female between 50 and 80 years of age
2. A recent closed Colles fracture, correctly reduced and stabilised
3. Willing, able to understand and sign an approved informed consent form
4. Able to understand the protocol and to come to the control visits

Exclusion Criteria

1. Fractures not meeting inclusion criteria (including pathological fractures)
2. Previous or concomitant treatment that may influence recovery
3. Concomittant treatments interfering with bone metabolism

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison between the two treatments, of the time to radiological healing in the two groups

Secondary Outcome Measures

Name	Time	Method
<br> Comparison between the two groups of:<br> 1. Time to disappearance of fracture line<br> 2. Time to full normal activity of daily living involving the target upper limb<br> 3. Percentage of patients with at least one adverse event occurring under treatment<br>