Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial
Identifieur interne : 001F67 ( Pmc/Checkpoint ); précédent : 001F66; suivant : 001F68Efficacy 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.
Url:
DOI: 10.1136/annrheumdis-2012-202231
PubMed: 23117245
PubMed Central: 3599139
Affiliations:
- Australie, Belgique, Canada, Danemark, Espagne, France, Pologne, Royaume-Uni, Russie, États-Unis
- Angleterre, Auvergne-Rhône-Alpes, Californie, District fédéral central, Grand Londres, Oxfordshire, Province de Liège, Rhône-Alpes, Région wallonne, Île-de-France
- Créteil, Liège, Londres, Lyon, Moscou, Oxford
- Université de Liège
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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 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wicri:step="Checkpoint">001F67</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial</title><author><name sortKey="Reginster, Jean Yves" sort="Reginster, Jean Yves" uniqKey="Reginster J" first="Jean-Yves" last="Reginster">Jean-Yves Reginster</name><affiliation wicri:level="4"><nlm:aff id="af1">Department of Public Health Epidemiology and Health Economics, University of Liege, Liege, Belgium</nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>Department of Public Health Epidemiology and Health Economics, University of Liege, Liege</wicri:regionArea><orgName type="university">Université de Liège</orgName><placeName><settlement type="city">Liège</settlement><region type="region" 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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<front><journal-meta><journal-id journal-id-type="nlm-ta">Ann Rheum Dis</journal-id><journal-id journal-id-type="iso-abbrev">Ann. Rheum. Dis</journal-id><journal-id journal-id-type="hwp">annrheumdis</journal-id><journal-id journal-id-type="publisher-id">ard</journal-id><journal-title-group><journal-title>Annals of the Rheumatic Diseases</journal-title></journal-title-group><issn pub-type="ppub">0003-4967</issn><issn pub-type="epub">1468-2060</issn><publisher><publisher-name>BMJ Publishing Group</publisher-name><publisher-loc>BMA House, Tavistock Square, London, WC1H 9JR</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">23117245</article-id><article-id pub-id-type="pmc">3599139</article-id><article-id pub-id-type="publisher-id">annrheumdis-2012-202231</article-id><article-id pub-id-type="doi">10.1136/annrheumdis-2012-202231</article-id><article-categories><subj-group subj-group-type="heading"><subject>Clinical and Epidemiological Research</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>1506</subject><subject>1507</subject></subj-group><series-title>Extended report</series-title></article-categories><title-group><article-title>Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Reginster</surname><given-names>Jean-Yves</given-names></name><xref ref-type="aff" rid="af1">1</xref></contrib><contrib contrib-type="author"><name><surname>Badurski</surname><given-names>Janusz</given-names></name><xref ref-type="aff" rid="af2">2</xref></contrib><contrib contrib-type="author"><name><surname>Bellamy</surname><given-names>Nicholas</given-names></name><xref ref-type="aff" rid="af3">3</xref></contrib><contrib contrib-type="author"><name><surname>Bensen</surname><given-names>William</given-names></name><xref ref-type="aff" rid="af4">4</xref></contrib><contrib contrib-type="author"><name><surname>Chapurlat</surname><given-names>Roland</given-names></name><xref ref-type="aff" rid="af5">5</xref></contrib><contrib contrib-type="author"><name><surname>Chevalier</surname><given-names>Xavier</given-names></name><xref ref-type="aff" rid="af6">6</xref></contrib><contrib contrib-type="author"><name><surname>Christiansen</surname><given-names>Claus</given-names></name><xref ref-type="aff" rid="af7">7</xref></contrib><contrib contrib-type="author"><name><surname>Genant</surname><given-names>Harry</given-names></name><xref ref-type="aff" rid="af8">8</xref></contrib><contrib contrib-type="author"><name><surname>Navarro</surname><given-names>Federico</given-names></name><xref ref-type="aff" rid="af9">9</xref></contrib><contrib contrib-type="author"><name><surname>Nasonov</surname><given-names>Evgeny</given-names></name><xref ref-type="aff" rid="af10">10</xref></contrib><contrib contrib-type="author"><name><surname>Sambrook</surname><given-names>Philip N</given-names></name><xref ref-type="aff" rid="af11">11</xref></contrib><contrib contrib-type="author"><name><surname>Spector</surname><given-names>Timothy D</given-names></name><xref ref-type="aff" rid="af12">12</xref></contrib><contrib contrib-type="author"><name><surname>Cooper</surname><given-names>Cyrus</given-names></name><xref ref-type="aff" rid="af13">13</xref></contrib></contrib-group><aff id="af1"><label>1</label>Department of Public Health Epidemiology and Health Economics, University of Liege, Liege, Belgium</aff><aff id="af2"><label>2</label>Centre of Osteoporosis and Osteoarticular Diseases, Bialystok, Poland</aff><aff id="af3"><label>3</label>Centre of National Research on Disability (CONROD), University of Queensland, Herston, Queensland, Australia</aff><aff id="af4"><label>4</label>DeGroot School of Medicine, McMaster University Hamilton, Hamilton, Ontario, Canada</aff><aff id="af5"><label>5</label>INSERM UMR 1033, Service de Rhumatologie et Pathologie Osseuse, Hôpital Edouard Herriot, Université de Lyon, Lyon, France</aff><aff id="af6"><label>6</label>Service de Rhumatologie, Hôpital Henri Mondor, Créteil, France</aff><aff id="af7"><label>7</label>Synarc, Centre for Clinical and Basic Research (CCBR), Ballerup, Denmark</aff><aff id="af8"><label>8</label>Radiology, Medicine, Epidemiology and Orthopedic Surgery, University of California, San Francisco and Synarc, San Francisco, California, USA</aff><aff id="af9"><label>9</label>Rheumatology Department, Hospital Universitario Virgen Macarena, Sevilla, Spain</aff><aff id="af10"><label>10</label>State Institute of Rheumatology, Russian Academy of Medical Sciences, Moscow, Russian Federation</aff><aff id="af11"><label>11</label>Institute of Bone and Joint Research, Royal North Shore Hospital, St Leonards, NSW, Australia</aff><aff id="af12"><label>12</label>Department of Twin Research and Genetic Epidemiology, Kings College London, St Thomas’ Hospital, London, UK</aff><aff id="af13"><label>13</label>MRC Lifecourse Epidemiology Unit, NIHR Musculoskeletal Biomedical Research Unit, University of Southampton, University of Oxford, Oxford, UK</aff><author-notes><corresp><label>Correspondence to</label> Professor Jean-Yves Reginster, Department of Public Health and Health Economics, University of Liege, 4020 Liege, Belgium; <email>jyreginster@ulg.ac.be</email></corresp></author-notes><pub-date pub-type="ppub"><month>2</month><year>2013</year></pub-date><pub-date pub-type="epub"><day>1</day><month>11</month><year>2012</year></pub-date><volume>72</volume><issue>2</issue><fpage>179</fpage><lpage>186</lpage><history><date date-type="accepted"><day>13</day><month>9</month><year>2012</year></date></history><permissions><copyright-statement>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</copyright-statement><copyright-year>2013</copyright-year><license license-type="open-access"><license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/">http://creativecommons.org/licenses/by-nc/3.0/</ext-link> and <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/legalcode">http://creativecommons.org/licenses/by-nc/3.0/legalcode</ext-link></license-p></license></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="annrheumdis-2012-202231.pdf"></self-uri><related-article id="d34e251" related-article-type="companion" ext-link-type="doi" xlink:href="10.1136/annrheumdis-2012-201710"></related-article><related-article id="d34e252" related-article-type="companion" ext-link-type="doi" xlink:href="10.1136/annrheumdis-2012-202239"></related-article><related-article id="d34e253" related-article-type="companion" ext-link-type="doi" xlink:href="10.1136/annrheumdis-2012-202453"></related-article><abstract><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></abstract><kwd-group><kwd>Knee Osteoarthritis</kwd><kwd>Osteoarthritis</kwd><kwd>Outcomes research</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>special-feature</meta-name><meta-value>unlocked</meta-value></custom-meta><custom-meta><meta-name>special-feature</meta-name><meta-value>editors-choice</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc><affiliations><list><country><li>Australie</li><li>Belgique</li><li>Canada</li><li>Danemark</li><li>Espagne</li><li>France</li><li>Pologne</li><li>Royaume-Uni</li><li>Russie</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Auvergne-Rhône-Alpes</li><li>Californie</li><li>District fédéral central</li><li>Grand Londres</li><li>Oxfordshire</li><li>Province de Liège</li><li>Rhône-Alpes</li><li>Région wallonne</li><li>Île-de-France</li></region><settlement><li>Créteil</li><li>Liège</li><li>Londres</li><li>Lyon</li><li>Moscou</li><li>Oxford</li></settlement><orgName><li>Université de Liège</li></orgName></list><tree><country name="Belgique"><region name="Région wallonne"><name sortKey="Reginster, Jean Yves" sort="Reginster, Jean Yves" uniqKey="Reginster J" first="Jean-Yves" last="Reginster">Jean-Yves Reginster</name></region></country><country name="Pologne"><noRegion><name sortKey="Badurski, Janusz" sort="Badurski, Janusz" uniqKey="Badurski J" first="Janusz" last="Badurski">Janusz Badurski</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Bellamy, Nicholas" sort="Bellamy, Nicholas" uniqKey="Bellamy N" first="Nicholas" last="Bellamy">Nicholas Bellamy</name></noRegion><name sortKey="Sambrook, Philip N" sort="Sambrook, Philip N" uniqKey="Sambrook P" first="Philip N" last="Sambrook">Philip N. Sambrook</name></country><country name="Canada"><noRegion><name sortKey="Bensen, William" sort="Bensen, William" uniqKey="Bensen W" first="William" last="Bensen">William Bensen</name></noRegion></country><country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Chapurlat, Roland" sort="Chapurlat, Roland" uniqKey="Chapurlat R" first="Roland" last="Chapurlat">Roland Chapurlat</name></region><name sortKey="Chevalier, Xavier" sort="Chevalier, Xavier" uniqKey="Chevalier X" first="Xavier" last="Chevalier">Xavier Chevalier</name></country><country name="Danemark"><noRegion><name sortKey="Christiansen, Claus" sort="Christiansen, Claus" uniqKey="Christiansen C" first="Claus" last="Christiansen">Claus Christiansen</name></noRegion></country><country name="États-Unis"><region name="Californie"><name sortKey="Genant, Harry" sort="Genant, Harry" uniqKey="Genant H" first="Harry" last="Genant">Harry Genant</name></region></country><country name="Espagne"><noRegion><name sortKey="Navarro, Federico" sort="Navarro, Federico" uniqKey="Navarro F" first="Federico" last="Navarro">Federico Navarro</name></noRegion></country><country name="Russie"><region name="District fédéral central"><name sortKey="Nasonov, Evgeny" sort="Nasonov, Evgeny" uniqKey="Nasonov E" first="Evgeny" last="Nasonov">Evgeny Nasonov</name></region></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Spector, Timothy D" sort="Spector, Timothy D" uniqKey="Spector T" first="Timothy D" last="Spector">Timothy D. 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