Additional identifiers
EudraCT number
2005-002494-75
ClinicalTrials.gov number
Protocol/serial number
CL3-12911-018
Study information
Scientific title
The efficacy and safety of two doses of strontium ranelate (1g and 2g per day) versus placebo administered orally for 3 years in the treatment of knee osteoarthritis. A prospective multicentre, international, double-blind, placebo-controlled study.
Acronym
Study hypothesis
To demonstrate the superiority of strontium ranelate versus placebo against articular cartilage damage progression over three years in men and women with knee osteoarthritis
Please note, as of 01/03/2011 the following updates have been made to this record:
1. The anticipated end date for this trial has been moved from 15/04/2009 to 30/03/2011
2. The public title has been updated. The previous title was 'The efficacy and safety of two doses of strontium ranelate versus placebo, administered orally for two years in the treatment of knee osteoarthritis. A prospective multicentre, international, double-blind, placebo-controlled study'.
3. The study hypothesis has been updated. The previous hypothesis was 'To demonstrate the superiority of strontium ranelate versus placebo against articular cartilage damage progression over two years in men and women with knee osteoarthritis'.
4. The target number of participants has been increased from 960 to 1680.
Ethics approval
First ethics committee approval given by the Ethical Committee of the Ospitalieri Institute of Verona on 14/12/2005, reference number: 1260)
Study design
Prospective multicentre international double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Osteoarthritis
Intervention
Strontium ranelate versus placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Strontium ranelate
Primary outcome measures
Radiographic assessment of knee osteoarthritis
Secondary outcome measures
1. Algofunctional assessment
2. Physical examination
3. Safety
Overall trial start date
15/04/2006
Overall trial end date
30/03/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Caucasian men and women of at least 50 years of age
2. Primary knee osteoarthritis
3. Under effective contraceptive method for non-menopausal women
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Added 01/03/2011: 1680 (960 at time of registration)
Participant exclusion criteria
1. Knee prosthesis already implanted or foreseen within the next year
2. Hip prosthesis recently implanted (<1 year) or not well-tolerated, or foreseen within the next year
Recruitment start date
15/04/2006
Recruitment end date
30/03/2011
Locations
Countries of recruitment
Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Estonia, France, Germany, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain, United Kingdom
Trial participating centre
University of Southampton
Southampton
SO16 6YD
United Kingdom
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
Current version as of 28/03/2018:
Summary results are published in 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.
Previous version as of 24/01/2018:
Publication plan:
All phases - Interventional studies ending before 01/10/2018: Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
All phases - Interventional studies ending after 01/10/2018: Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
Phase 3 only - The results will be published in scientific literature within 18 months after the end of the study.
IPD sharing statement:
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 2014.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
http://clinicaltrials.servier.com/wp-content/uploads/CL3-12911-018_synopsis_report.pdf
Publication summary
2013 results in https://www.ncbi.nlm.nih.gov/pubmed/23117245
2014 results in https://www.ncbi.nlm.nih.gov/pubmed/24667161
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/24297379
Publication citations
-
Results
Bruyère O, Reginster JY, Bellamy N, Chapurlat R, Richette P, Cooper C, , Clinically meaningful effect of strontium ranelate on symptoms in knee osteoarthritis: a responder analysis., Rheumatology (Oxford), 2014, 53, 8, 1457-1464, doi: 10.1093/rheumatology/keu018.