The fracture healing study
Research type
Research Study
Full title
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.
IRAS ID
39480
Contact name
David Marsh
Sponsor organisation
Institut de Recherches Internationales Servier
Eudract number
2009-014271-41
ISRCTN Number
Not Sent
Research summary
Elderly patients with osteoporosis have an increased time to fracture healing. Strontium ranelate is a treatment for osteoporosis and this study is looking at the effect of strontium ranelate on the fracture healing time in osteoporotic patients with wrist fractures. To date there are no treatments on the market for the treatment of fractures. Patients will be treated as normal following their wrist fracture (they will still have their wrist put in a cast). However if a patient consents to being involved in the study they will have a bone mineral density scan in order to check if they are osteoporotic and if they are they will be randomly assigned into two groups: to take either strontium ranelate or placebo (a dummy drug) for a 24 week period. Patients will have a 50:50 chance of being assigned to either group. All patients, in both groups, will also be given calcium and vitamin D supplements, which are recommended for the treatment of osteoporosis. Patients will be followed up periodically (at week 4,6,7,8,9,10,12,14,16, 18 and 24 weeks post fracture) to assess the fracture healing, by X-ray, during the study. The study will also be looking at the time to return to normal function of the wrist and this will be assessed by various questionnaires and looking at the patients?? hand function using a test that demonstrates how well the patient??s hand can grip.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
10/H0713/28
Date of REC Opinion
26 May 2010
REC opinion
Further Information Favourable Opinion