Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CL3-12911-022
Study information
Scientific title
The efficacy and safety of two doses of strontium ranelate 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.
Ethics approval
Ethics approval was obtained before recruitment of the first participants
Study design
Randomised double-blind parallel-group placebo-controlled trial
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
Osteoarthritis
Intervention
The treatment is composed of two doses of strontium ranelate (1 g and 2 g per day) administered orally for 3 years.
Intervention type
Drug
Phase
Phase III
Drug names
Strontium ranelate
Primary outcome measure
Radiographic assessment of knee osteoarthritis measured up to 36 months
Secondary outcome measures
Measured up to 36 months:
1. Algofunctional assessment
2. Physical examination
3. Safety
Overall trial start date
30/06/2008
Overall trial end date
30/04/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Asia men and women of at least 50 years of age
2. Primary knee osteoarthritis
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
450
Participant exclusion criteria
1. Knee prosthesis already implanted or foreseen within the next year
2. Hip prosthesis recently implanted (less than 1 year) or not well-tolerated, or foreseen within the next year
Recruitment start date
30/06/2008
Recruitment end date
30/04/2013
Locations
Countries of recruitment
China, Korea, South, Taiwan
Trial participating centre
Rheumatology and Clinical Immunology Division
Beijing
100730
China
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
Summary results are published on https://clinicaltrials.servier.com/.
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
Basic results (scientific)
http://clinicaltrials.servier.com/wp-content/uploads/CL3-12911-022_synopsis_report.pdf
Publication list