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ISRCTN
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ISRCTN51868986
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ClinicalTrials.gov identifier
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Public title
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Efficacy of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and osteoporotic post-menopausal women
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Scientific title
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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
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Acronym
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The “Fracture healing” study
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Serial number at source
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CL3-12911-035
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Study hypothesis
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To demonstrate the efficacy of strontium ranelate 2 g versus placebo in accelerating radiological healing of distal radius fractures.
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Lay summary
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Ethics approval
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Ethics approval was obtained before recruitment of the first participants
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Study design
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Randomised double blind placebo controlled study
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Countries of recruitment
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Brazil, Czech Republic, France, Germany, Hungary, Italy, United Kingdom
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Disease/condition/study domain
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Radius fracture, Osteoporosis
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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1. Fractures not meeting inclusion criteria (including displaced radius fractures)
2. Concomitant treatments likely to interfere with bone metabolism
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Anticipated start date
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01/05/2010
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Anticipated end date
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31/03/2012
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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200
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Interventions
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One daily administration of strontium ranelate 2 g or placebo during 24 weeks. There is no visit after the last intake at week-24.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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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
Maria
Brandi
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Address
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University of Florence
Department of Internal Medicine
Division of Rheumatology and Metabolic bone Disease
Viale Pieraccini, 18
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City/town
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Florence
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Zip/Postcode
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50139
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Country
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Italy
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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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28/05/2010
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Last edited
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09/05/2011
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Date ISRCTN assigned
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05/07/2010
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