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ISRCTN
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ISRCTN41323372
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ClinicalTrials.gov identifier
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Public title
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The efficacy and safety of two doses of strontium ranelate versus placebo, administered orally for three years in the treatment of knee osteoarthritis
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Scientific title
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Acronym
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N/A
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Serial number at source
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CL3-12911-018
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Study hypothesis
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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:
-The anticipated end date for this trial has been moved from 15/04/2009 to 30/03/2011
-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'.
- 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'.
- The target number of participants has been increased from 960 to 1680.
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Lay summary
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Ethics approval
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First ethics committee approval given by the Ethical Committee of the Ospitalieri Institute of Verona on 14/12/2005, reference number: 1260)
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Study design
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A prospective multicentre, international, double-blind, placebo-controlled study
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Countries of recruitment
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Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Estonia, France, Germany, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain, United Kingdom
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Disease/condition/study domain
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Osteoarthritis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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15/04/2006
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Anticipated end date
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30/03/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Added 01/03/2011: 1680 (960 at time of registration)
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Interventions
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Strontium ranelate versus placebo
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Primary outcome measure(s)
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Radiographic assessment of knee osteoarthritis
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Secondary outcome measure(s)
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1. Algofunctional assessment
2. Physical examination
3. Safety
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Sources of funding
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Institut de Recherches Internationales Servier (France)
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Trial website
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Publications
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Contact name
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Prof
Cyrus
Cooper
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Address
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University of Southampton
Southampton General Hospital
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City/town
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Southampton
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Zip/Postcode
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SO16 6YD
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Country
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United Kingdom
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Sponsor
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Institut de Recherches Internationales Servier (France)
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Address
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6 Place des Pléiades
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City/town
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Courbevoie
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Zip/Postcode
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92415
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Country
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France
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Date applied
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05/05/2006
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Last edited
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01/03/2011
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Date ISRCTN assigned
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13/06/2006
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