Additional identifiers
EudraCT number
2009-014271-41
ClinicalTrials.gov number
Protocol/serial number
CL3-12911-035
Study information
Scientific title
A multicentre, prospective, randomised, double-blind, placebo-controlled, international study to assess the effects of 2 g per day of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and women
Acronym
The Fracture healing study
Study hypothesis
To demonstrate the efficacy of strontium ranelate 2 g versus placebo in accelerating radiological healing of distal radius fractures.
Please note that as of 27/11/2012, Belgium, Russian Federation and Ukraine were added to the countries of recruitment.
Ethics approval
Ethics approval was obtained before recruitment of the first participants
Study design
Randomised double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Radius fracture, Osteoporosis
Intervention
One daily administration of strontium ranelate 2 g or placebo during 24 weeks. There is no visit after the last intake at week-24.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
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
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.
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
3. Safety evaluation, performed at least once every 4 weeks from baseline to week 18 and at the last study visit
Overall trial start date
01/05/2010
Overall trial end date
31/03/2012
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Fractures not meeting inclusion criteria (including displaced radius fractures)
2. Concomitant treatments likely to interfere with bone metabolism
Recruitment start date
01/05/2010
Recruitment end date
31/03/2012
Locations
Countries of recruitment
Belgium, Brazil, Czech Republic, France, Germany, Hungary, Italy, Russian Federation, Ukraine, United Kingdom
Trial participating centre
University of Florence
Florence
50139
Italy
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication plan:
Summary results are published on https://clinicaltrials.servier.com.
For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
http://clinicaltrials.servier.com/wp-content/uploads/CL3-12911-035_synopsis_report.pdf
Publication summary