Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial
Identifieur interne : 001025 ( Ncbi/Curation ); précédent : 001024; suivant : 001026Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial
Auteurs : Jean-Yves Reginster [Belgique] ; Janusz Badurski [Pologne] ; Nicholas Bellamy [Australie] ; William Bensen [Canada] ; Roland Chapurlat [France] ; Xavier Chevalier [France] ; Claus Christiansen [Danemark] ; Harry Genant [États-Unis] ; Federico Navarro [Espagne] ; Evgeny Nasonov [Russie] ; Philip N. Sambrook [Australie] ; Timothy D. Spector [Royaume-Uni] ; Cyrus Cooper [Royaume-Uni]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2012.
Abstract
Strontium ranelate is currently used for osteoporosis. The international, double-blind, randomised, placebo-controlled Strontium ranelate Efficacy in Knee OsteoarthrItis triAl evaluated its effect on radiological progression of knee osteoarthritis.
Patients with knee osteoarthritis (Kellgren and Lawrence grade 2 or 3, and joint space width (JSW) 2.5–5 mm) were randomly allocated to strontium ranelate 1 g/day (n=558), 2 g/day (n=566) or placebo (n=559). The primary endpoint was radiographical change in JSW (medial tibiofemoral compartment) over 3 years versus placebo. Secondary endpoints included radiological progression, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and knee pain. The trial is registered (ISRCTN41323372).
The intention-to-treat population included 1371 patients. Treatment with strontium ranelate was associated with smaller degradations in JSW than placebo (1 g/day: −0.23 (SD 0.56) mm; 2 g/day: −0.27 (SD 0.63) mm; placebo: −0.37 (SD 0.59) mm); treatment-placebo differences were 0.14 (SE 0.04), 95% CI 0.05 to 0.23, p<0.001 for 1 g/day and 0.10 (SE 0.04), 95% CI 0.02 to 0.19, p=0.018 for 2 g/day. Fewer radiological progressors were observed with strontium ranelate (p<0.001 and p=0.012 for 1 and 2 g/day). There were greater reductions in total WOMAC score (p=0.045), pain subscore (p=0.028), physical function subscore (p=0.099) and knee pain (p=0.065) with strontium ranelate 2 g/day. Strontium ranelate was well tolerated.
Treatment with strontium ranelate 1 and 2 g/day is associated with a significant effect on structure in patients with knee osteoarthritis, and a beneficial effect on symptoms for strontium ranelate 2 g/day.
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DOI: 10.1136/annrheumdis-2012-202231
PubMed: 23117245
PubMed Central: 3599139
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last="Navarro">Federico Navarro</name><affiliation wicri:level="1"><nlm:aff id="af9">Rheumatology Department, Hospital Universitario Virgen Macarena, Sevilla, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Rheumatology Department, Hospital Universitario Virgen Macarena, Sevilla</wicri:regionArea><wicri:noRegion>Sevilla</wicri:noRegion></affiliation></author><author><name sortKey="Nasonov, Evgeny" sort="Nasonov, Evgeny" uniqKey="Nasonov E" first="Evgeny" last="Nasonov">Evgeny Nasonov</name><affiliation wicri:level="3"><nlm:aff id="af10">State Institute of Rheumatology, Russian Academy of Medical Sciences, Moscow, Russian Federation</nlm:aff><country xml:lang="fr">Russie</country><wicri:regionArea>State Institute of Rheumatology, Russian Academy of Medical Sciences, Moscow</wicri:regionArea><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></affiliation></author><author><name sortKey="Sambrook, Philip N" sort="Sambrook, Philip N" uniqKey="Sambrook P" first="Philip N" last="Sambrook">Philip N. Sambrook</name><affiliation wicri:level="1"><nlm:aff id="af11">Institute of Bone and Joint Research, Royal North Shore Hospital, St Leonards, NSW, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Institute of Bone and Joint Research, Royal North Shore Hospital, St Leonards, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Spector, Timothy D" sort="Spector, Timothy D" uniqKey="Spector T" first="Timothy D" last="Spector">Timothy D. 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nuts="1">Région wallonne</region><region type="province" nuts="1">Province de Liège</region></placeName></affiliation></author><author><name sortKey="Badurski, Janusz" sort="Badurski, Janusz" uniqKey="Badurski J" first="Janusz" last="Badurski">Janusz Badurski</name><affiliation wicri:level="1"><nlm:aff id="af2">Centre of Osteoporosis and Osteoarticular Diseases, Bialystok, Poland</nlm:aff><country xml:lang="fr">Pologne</country><wicri:regionArea>Centre of Osteoporosis and Osteoarticular Diseases, Bialystok</wicri:regionArea><wicri:noRegion>Bialystok</wicri:noRegion></affiliation></author><author><name sortKey="Bellamy, Nicholas" sort="Bellamy, Nicholas" uniqKey="Bellamy N" first="Nicholas" last="Bellamy">Nicholas Bellamy</name><affiliation wicri:level="1"><nlm:aff id="af3">Centre of National Research on Disability (CONROD), University of Queensland, Herston, Queensland, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Centre of National Research on Disability (CONROD), University of Queensland, Herston, Queensland</wicri:regionArea><wicri:noRegion>Queensland</wicri:noRegion></affiliation></author><author><name sortKey="Bensen, William" sort="Bensen, William" uniqKey="Bensen W" first="William" last="Bensen">William Bensen</name><affiliation wicri:level="1"><nlm:aff id="af4">DeGroot School of Medicine, McMaster University Hamilton, Hamilton, Ontario, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>DeGroot School of Medicine, McMaster University Hamilton, Hamilton, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Chapurlat, Roland" sort="Chapurlat, Roland" uniqKey="Chapurlat R" first="Roland" last="Chapurlat">Roland Chapurlat</name><affiliation wicri:level="3"><nlm:aff id="af5">INSERM UMR 1033, Service de Rhumatologie et Pathologie Osseuse, Hôpital Edouard Herriot, Université de Lyon, Lyon, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>INSERM UMR 1033, Service de Rhumatologie et Pathologie Osseuse, Hôpital Edouard Herriot, Université de Lyon, Lyon</wicri:regionArea><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Chevalier, Xavier" sort="Chevalier, Xavier" uniqKey="Chevalier X" first="Xavier" last="Chevalier">Xavier Chevalier</name><affiliation wicri:level="3"><nlm:aff id="af6">Service de Rhumatologie, Hôpital Henri Mondor, Créteil, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Service de Rhumatologie, Hôpital Henri Mondor, Créteil</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Créteil</settlement></placeName></affiliation></author><author><name sortKey="Christiansen, Claus" sort="Christiansen, Claus" uniqKey="Christiansen C" first="Claus" last="Christiansen">Claus Christiansen</name><affiliation wicri:level="1"><nlm:aff id="af7">Synarc, Centre for Clinical and Basic Research (CCBR), Ballerup, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Synarc, Centre for Clinical and Basic Research (CCBR), Ballerup</wicri:regionArea><wicri:noRegion>Ballerup</wicri:noRegion></affiliation></author><author><name sortKey="Genant, Harry" sort="Genant, Harry" uniqKey="Genant H" first="Harry" last="Genant">Harry Genant</name><affiliation wicri:level="2"><nlm:aff id="af8">Radiology, Medicine, Epidemiology and Orthopedic Surgery, University of California, San Francisco and Synarc, San Francisco, California, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Radiology, Medicine, Epidemiology and Orthopedic Surgery, University of California, San Francisco and Synarc, San Francisco, California</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Navarro, Federico" sort="Navarro, Federico" uniqKey="Navarro F" first="Federico" last="Navarro">Federico Navarro</name><affiliation wicri:level="1"><nlm:aff id="af9">Rheumatology Department, Hospital Universitario Virgen Macarena, Sevilla, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Rheumatology Department, Hospital Universitario Virgen Macarena, Sevilla</wicri:regionArea><wicri:noRegion>Sevilla</wicri:noRegion></affiliation></author><author><name sortKey="Nasonov, Evgeny" sort="Nasonov, Evgeny" uniqKey="Nasonov E" first="Evgeny" last="Nasonov">Evgeny Nasonov</name><affiliation wicri:level="3"><nlm:aff id="af10">State Institute of Rheumatology, Russian Academy of Medical Sciences, Moscow, Russian Federation</nlm:aff><country xml:lang="fr">Russie</country><wicri:regionArea>State Institute of Rheumatology, Russian Academy of Medical Sciences, Moscow</wicri:regionArea><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></affiliation></author><author><name sortKey="Sambrook, Philip N" sort="Sambrook, Philip N" uniqKey="Sambrook P" first="Philip N" last="Sambrook">Philip N. Sambrook</name><affiliation wicri:level="1"><nlm:aff id="af11">Institute of Bone and Joint Research, Royal North Shore Hospital, St Leonards, NSW, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Institute of Bone and Joint Research, Royal North Shore Hospital, St Leonards, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Spector, Timothy D" sort="Spector, Timothy D" uniqKey="Spector T" first="Timothy D" last="Spector">Timothy D. Spector</name><affiliation wicri:level="3"><nlm:aff id="af12">Department of Twin Research and Genetic Epidemiology, Kings College London, St Thomas’ Hospital, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Twin Research and Genetic Epidemiology, Kings College London, St Thomas’ Hospital, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Cooper, Cyrus" sort="Cooper, Cyrus" uniqKey="Cooper C" first="Cyrus" last="Cooper">Cyrus Cooper</name><affiliation wicri:level="3"><nlm:aff id="af13">MRC Lifecourse Epidemiology Unit, NIHR Musculoskeletal Biomedical Research Unit, University of Southampton, University of Oxford, Oxford, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>MRC Lifecourse Epidemiology Unit, NIHR Musculoskeletal Biomedical Research Unit, University of Southampton, University of Oxford, Oxford</wicri:regionArea><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region></placeName></affiliation></author></analytic><series><title level="j">Annals of the Rheumatic Diseases</title><idno type="ISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Strontium ranelate is currently used for osteoporosis. The international, double-blind, randomised, placebo-controlled Strontium ranelate Efficacy in Knee OsteoarthrItis triAl evaluated its effect on radiological progression of knee osteoarthritis.</p></sec><sec><title>Methods</title><p>Patients with knee osteoarthritis (Kellgren and Lawrence grade 2 or 3, and joint space width (JSW) 2.5–5 mm) were randomly allocated to strontium ranelate 1 g/day (n=558), 2 g/day (n=566) or placebo (n=559). The primary endpoint was radiographical change in JSW (medial tibiofemoral compartment) over 3 years versus placebo. Secondary endpoints included radiological progression, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and knee pain. The trial is registered (ISRCTN41323372).</p></sec><sec><title>Results</title><p>The intention-to-treat population included 1371 patients. Treatment with strontium ranelate was associated with smaller degradations in JSW than placebo (1 g/day: −0.23 (SD 0.56) mm; 2 g/day: −0.27 (SD 0.63) mm; placebo: −0.37 (SD 0.59) mm); treatment-placebo differences were 0.14 (SE 0.04), 95% CI 0.05 to 0.23, p<0.001 for 1 g/day and 0.10 (SE 0.04), 95% CI 0.02 to 0.19, p=0.018 for 2 g/day. Fewer radiological progressors were observed with strontium ranelate (p<0.001 and p=0.012 for 1 and 2 g/day). There were greater reductions in total WOMAC score (p=0.045), pain subscore (p=0.028), physical function subscore (p=0.099) and knee pain (p=0.065) with strontium ranelate 2 g/day. Strontium ranelate was well tolerated.</p></sec><sec><title>Conclusions</title><p>Treatment with strontium ranelate 1 and 2 g/day is associated with a significant effect on structure in patients with knee osteoarthritis, and a beneficial effect on symptoms for strontium ranelate 2 g/day.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Bijlsma, Jw" uniqKey="Bijlsma J">JW Bijlsma</name></author><author><name sortKey="Berenbaum, F" uniqKey="Berenbaum F">F Berenbaum</name></author><author><name sortKey="Lafeber, Fp" uniqKey="Lafeber F">FP Lafeber</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cooper, C" uniqKey="Cooper C">C Cooper</name></author><author><name sortKey="Arden, Nk" uniqKey="Arden N">NK Arden</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Zhang, W" uniqKey="Zhang W">W Zhang</name></author><author><name sortKey="Nuki, G" uniqKey="Nuki G">G 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Finco</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Brandt, Kd" uniqKey="Brandt K">KD Brandt</name></author><author><name sortKey="Mazzuca, Sa" uniqKey="Mazzuca S">SA Mazzuca</name></author><author><name sortKey="Katz, Bp" uniqKey="Katz B">BP Katz</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Michel, Ba" uniqKey="Michel B">BA Michel</name></author><author><name sortKey="Stucki, G" uniqKey="Stucki G">G Stucki</name></author><author><name sortKey="Frey, D" uniqKey="Frey D">D Frey</name></author></analytic></biblStruct></listBibl></div1></back></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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