AB0962 Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: A randomized, double-blind, placebo-controlled international trial
Identifieur interne : 002956 ( Istex/Corpus ); précédent : 002955; suivant : 002957AB0962 Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: A randomized, double-blind, placebo-controlled international trial
Auteurs : C. Cooper ; R. Chapurlat ; C. Christiansen ; H. Genant ; N. Bellamy ; W. Bensen ; F. Navarro ; J. Badurski ; E. Nasonov ; X. Chevalier ; P. Sambrook ; T. Spector ; J.-Y. ReginsterSource :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2013-06.
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Abstract
Background Strontium ranelate (SrRan) has potential beneficial effects on cartilage degradation in OA, stimulating human cartilage matrix formation in vitro and decreasing the urinary C-terminal telopeptides of type II-collagen. SrRan has also been shown to reduce radiographic spinal OA progression and back pain in osteoporotic women with prevalent spinal OA. Objectives We compared the efficacy and safety of SrRan with placebo in the treatment of knee osteoarthritis in a double-blind, placebo-controlled, randomised, international study (registration number: ISRCTN41323372) designed in accordance with the European Guidelines. Methods Patients with primary knee osteoarthritis, Kellgren and Lawrence grade 2 or 3, joint space width (JSW) 2.5 to 5 mm, and knee pain intensity of at least 40 mm on a visual analogue scale during the month prior to selection, were randomly allocated to SrRan 1 or 2 g/day, or placebo using a centralised interactive voice response system. The primary endpoint was radiographic joint space narrowing measured as the mean change in the minimal JSW of the knee medial tibiofemoral compartment with a semiautomated centralised reading method. JSW was measured at inclusion, 12, 24, and 36 months on radiographs with a postero-anterior, weight-bearing, fixed-flexion acquisition technique. Main secondary endpoints were changes in algofunctional scores (WOMAC), changes in knee pain intensity, and proportion of radiological progressors (patients with knee JSN>0.5 mm). Safety was assessed by adverse events and haematology/biochemistry/haemostasis parameters. Results Detailed results will be presented. The patients were included in 113 centres in 18 countries. 558 patients were assigned to SrRan 1 g/day, 566 to 2 g/day, and 559 to placebo. Mean follow-up was 29.8±10.5 months. Mean age was 62.8±7.2 years and 69% were female. Mean BMI was 30±5 kg/m2, mean JSW was 3.50±0.83 mm, and 61% of randomised patients were Kellgren and Lawrence stage II. Conclusions This large randomised placebo-controlled study will establish the long-term efficacyof SrRan on structure and symptoms in patients with knee osteoarthritis. Disclosure of Interest None Declared
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DOI: 10.1136/annrheumdis-2012-eular.962
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">AB0962 Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: A randomized, double-blind, placebo-controlled international trial</title><author><name sortKey="Cooper, C" sort="Cooper, C" uniqKey="Cooper C" first="C." last="Cooper">C. Cooper</name><affiliation><mods:affiliation>MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom</mods:affiliation></affiliation><affiliation><mods:affiliation>MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Chapurlat, R" sort="Chapurlat, R" uniqKey="Chapurlat R" first="R." last="Chapurlat">R. Chapurlat</name><affiliation><mods:affiliation>INSERM UMR 1033 and Université de Lyon, Hôpital Edouard Herriot, Lyon, France</mods:affiliation></affiliation><affiliation><mods:affiliation>INSERM UMR 1033 and Université de Lyon, Hôpital Edouard Herriot, Lyon, France</mods:affiliation></affiliation></author><author><name sortKey="Christiansen, C" sort="Christiansen, C" uniqKey="Christiansen C" first="C." last="Christiansen">C. Christiansen</name><affiliation><mods:affiliation>CCBR Ballerup, Ballerup, Denmark</mods:affiliation></affiliation><affiliation><mods:affiliation>CCBR Ballerup, Ballerup, Denmark</mods:affiliation></affiliation></author><author><name sortKey="Genant, H" sort="Genant, H" uniqKey="Genant H" first="H." last="Genant">H. Genant</name><affiliation><mods:affiliation>Radiology, Medicine and Orthopaedic Surgery University of California San Francisco, and Synarc, San Francisco, United States</mods:affiliation></affiliation><affiliation><mods:affiliation>Radiology, Medicine and Orthopaedic Surgery University of California San Francisco, and Synarc, San Francisco, United States</mods:affiliation></affiliation></author><author><name sortKey="Bellamy, N" sort="Bellamy, N" uniqKey="Bellamy N" first="N." last="Bellamy">N. Bellamy</name><affiliation><mods:affiliation>University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia</mods:affiliation></affiliation></author><author><name sortKey="Bensen, W" sort="Bensen, W" uniqKey="Bensen W" first="W." last="Bensen">W. Bensen</name><affiliation><mods:affiliation>McMaster University Hamilton, Ontario, Canada</mods:affiliation></affiliation><affiliation><mods:affiliation>McMaster University Hamilton, Ontario, Canada</mods:affiliation></affiliation></author><author><name sortKey="Navarro, F" sort="Navarro, F" uniqKey="Navarro F" first="F." last="Navarro">F. Navarro</name><affiliation><mods:affiliation>H. Clinico Virgen de la Macarena Servicio de Reumatologia, Sevilla, Spain</mods:affiliation></affiliation><affiliation><mods:affiliation>H. Clinico Virgen de la Macarena Servicio de Reumatologia, Sevilla, Spain</mods:affiliation></affiliation></author><author><name sortKey="Badurski, J" sort="Badurski, J" uniqKey="Badurski J" first="J." last="Badurski">J. Badurski</name><affiliation><mods:affiliation>Centre of Osteoporosis and Osteo– articular Diseases, Bialystock, Poland</mods:affiliation></affiliation><affiliation><mods:affiliation>Centre of Osteoporosis and Osteo– articular Diseases, Bialystock, Poland</mods:affiliation></affiliation></author><author><name sortKey="Nasonov, E" sort="Nasonov, E" uniqKey="Nasonov E" first="E." last="Nasonov">E. Nasonov</name><affiliation><mods:affiliation>State Institute of Rheumatology, the Russian Academy of Medical Sciences, Moscow, Russian Federation</mods:affiliation></affiliation><affiliation><mods:affiliation>State Institute of Rheumatology, the Russian Academy of Medical Sciences, Moscow, Russian Federation</mods:affiliation></affiliation></author><author><name sortKey="Chevalier, X" sort="Chevalier, X" uniqKey="Chevalier X" first="X." last="Chevalier">X. Chevalier</name><affiliation><mods:affiliation>Hôpital Henri Mondor, Créteil, France</mods:affiliation></affiliation><affiliation><mods:affiliation>Hôpital Henri Mondor, Créteil, France</mods:affiliation></affiliation></author><author><name sortKey="Sambrook, P" sort="Sambrook, P" uniqKey="Sambrook P" first="P." last="Sambrook">P. Sambrook</name><affiliation><mods:affiliation>Royal North Shore Hospital, St. Leonards NSW, Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal North Shore Hospital, St. Leonards NSW, Australia</mods:affiliation></affiliation></author><author><name sortKey="Spector, T" sort="Spector, T" uniqKey="Spector T" first="T." last="Spector">T. Spector</name><affiliation><mods:affiliation>Kings College London, St Thomas’ Campus, London, United Kingdom</mods:affiliation></affiliation><affiliation><mods:affiliation>Kings College London, St Thomas’ Campus, London, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Reginster, J Y" sort="Reginster, J Y" uniqKey="Reginster J" first="J.-Y." last="Reginster">J.-Y. Reginster</name><affiliation><mods:affiliation>University of Liège, Liège, Belgium</mods:affiliation></affiliation><affiliation><mods:affiliation>University of Liège, Liège, Belgium</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:DE63D260B906D9D4CC4E1468247F78DA72563F50</idno><date when="2013" year="2013">2013</date><idno type="doi">10.1136/annrheumdis-2012-eular.962</idno><idno type="url">https://api.istex.fr/document/DE63D260B906D9D4CC4E1468247F78DA72563F50/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">002956</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">002956</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">AB0962 Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: A randomized, double-blind, placebo-controlled international trial</title><author><name sortKey="Cooper, C" sort="Cooper, C" uniqKey="Cooper C" first="C." last="Cooper">C. Cooper</name><affiliation><mods:affiliation>MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom</mods:affiliation></affiliation><affiliation><mods:affiliation>MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Chapurlat, R" sort="Chapurlat, R" uniqKey="Chapurlat R" first="R." last="Chapurlat">R. Chapurlat</name><affiliation><mods:affiliation>INSERM UMR 1033 and Université de Lyon, Hôpital Edouard Herriot, Lyon, France</mods:affiliation></affiliation><affiliation><mods:affiliation>INSERM UMR 1033 and Université de Lyon, Hôpital Edouard Herriot, Lyon, France</mods:affiliation></affiliation></author><author><name sortKey="Christiansen, C" sort="Christiansen, C" uniqKey="Christiansen C" first="C." last="Christiansen">C. Christiansen</name><affiliation><mods:affiliation>CCBR Ballerup, Ballerup, Denmark</mods:affiliation></affiliation><affiliation><mods:affiliation>CCBR Ballerup, Ballerup, Denmark</mods:affiliation></affiliation></author><author><name sortKey="Genant, H" sort="Genant, H" uniqKey="Genant H" first="H." last="Genant">H. Genant</name><affiliation><mods:affiliation>Radiology, Medicine and Orthopaedic Surgery University of California San Francisco, and Synarc, San Francisco, United States</mods:affiliation></affiliation><affiliation><mods:affiliation>Radiology, Medicine and Orthopaedic Surgery University of California San Francisco, and Synarc, San Francisco, United States</mods:affiliation></affiliation></author><author><name sortKey="Bellamy, N" sort="Bellamy, N" uniqKey="Bellamy N" first="N." last="Bellamy">N. Bellamy</name><affiliation><mods:affiliation>University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia</mods:affiliation></affiliation></author><author><name sortKey="Bensen, W" sort="Bensen, W" uniqKey="Bensen W" first="W." last="Bensen">W. Bensen</name><affiliation><mods:affiliation>McMaster University Hamilton, Ontario, Canada</mods:affiliation></affiliation><affiliation><mods:affiliation>McMaster University Hamilton, Ontario, Canada</mods:affiliation></affiliation></author><author><name sortKey="Navarro, F" sort="Navarro, F" uniqKey="Navarro F" first="F." last="Navarro">F. Navarro</name><affiliation><mods:affiliation>H. Clinico Virgen de la Macarena Servicio de Reumatologia, Sevilla, Spain</mods:affiliation></affiliation><affiliation><mods:affiliation>H. Clinico Virgen de la Macarena Servicio de Reumatologia, Sevilla, Spain</mods:affiliation></affiliation></author><author><name sortKey="Badurski, J" sort="Badurski, J" uniqKey="Badurski J" first="J." last="Badurski">J. Badurski</name><affiliation><mods:affiliation>Centre of Osteoporosis and Osteo– articular Diseases, Bialystock, Poland</mods:affiliation></affiliation><affiliation><mods:affiliation>Centre of Osteoporosis and Osteo– articular Diseases, Bialystock, Poland</mods:affiliation></affiliation></author><author><name sortKey="Nasonov, E" sort="Nasonov, E" uniqKey="Nasonov E" first="E." last="Nasonov">E. Nasonov</name><affiliation><mods:affiliation>State Institute of Rheumatology, the Russian Academy of Medical Sciences, Moscow, Russian Federation</mods:affiliation></affiliation><affiliation><mods:affiliation>State Institute of Rheumatology, the Russian Academy of Medical Sciences, Moscow, Russian Federation</mods:affiliation></affiliation></author><author><name sortKey="Chevalier, X" sort="Chevalier, X" uniqKey="Chevalier X" first="X." last="Chevalier">X. Chevalier</name><affiliation><mods:affiliation>Hôpital Henri Mondor, Créteil, France</mods:affiliation></affiliation><affiliation><mods:affiliation>Hôpital Henri Mondor, Créteil, France</mods:affiliation></affiliation></author><author><name sortKey="Sambrook, P" sort="Sambrook, P" uniqKey="Sambrook P" first="P." last="Sambrook">P. Sambrook</name><affiliation><mods:affiliation>Royal North Shore Hospital, St. Leonards NSW, Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>Royal North Shore Hospital, St. Leonards NSW, Australia</mods:affiliation></affiliation></author><author><name sortKey="Spector, T" sort="Spector, T" uniqKey="Spector T" first="T." last="Spector">T. Spector</name><affiliation><mods:affiliation>Kings College London, St Thomas’ Campus, London, United Kingdom</mods:affiliation></affiliation><affiliation><mods:affiliation>Kings College London, St Thomas’ Campus, London, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Reginster, J Y" sort="Reginster, J Y" uniqKey="Reginster J" first="J.-Y." last="Reginster">J.-Y. Reginster</name><affiliation><mods:affiliation>University of Liège, Liège, Belgium</mods:affiliation></affiliation><affiliation><mods:affiliation>University of Liège, Liège, Belgium</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of the Rheumatic Diseases</title><title level="j" type="abbrev">Ann Rheum Dis</title><idno type="ISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><date type="published" when="2013-06">2013-06</date><biblScope unit="volume">71</biblScope><biblScope unit="issue">Suppl 3</biblScope><biblScope unit="page" from="693">693</biblScope></imprint><idno type="ISSN">0003-4967</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0003-4967</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Centre</term><term>General practice</term><term>Knee osteoarthritis</term><term>Medical imaging</term><term>Orthopaedic surgery</term><term>Orthopaedics</term><term>Osteoarthritis</term><term>Public health</term><term>Rheumatology</term><term>Rheumatology unit</term><term>Santa maria</term><term>Sint maartenskliniek</term><term>Victor babes</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Centre</term><term>General practice</term><term>Knee osteoarthritis</term><term>Medical imaging</term><term>Orthopaedic surgery</term><term>Orthopaedics</term><term>Osteoarthritis</term><term>Public health</term><term>Rheumatology</term><term>Rheumatology unit</term><term>Santa maria</term><term>Sint maartenskliniek</term><term>Victor babes</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Background Strontium ranelate (SrRan) has potential beneficial effects on cartilage degradation in OA, stimulating human cartilage matrix formation in vitro and decreasing the urinary C-terminal telopeptides of type II-collagen. SrRan has also been shown to reduce radiographic spinal OA progression and back pain in osteoporotic women with prevalent spinal OA. Objectives We compared the efficacy and safety of SrRan with placebo in the treatment of knee osteoarthritis in a double-blind, placebo-controlled, randomised, international study (registration number: ISRCTN41323372) designed in accordance with the European Guidelines. Methods Patients with primary knee osteoarthritis, Kellgren and Lawrence grade 2 or 3, joint space width (JSW) 2.5 to 5 mm, and knee pain intensity of at least 40 mm on a visual analogue scale during the month prior to selection, were randomly allocated to SrRan 1 or 2 g/day, or placebo using a centralised interactive voice response system. The primary endpoint was radiographic joint space narrowing measured as the mean change in the minimal JSW of the knee medial tibiofemoral compartment with a semiautomated centralised reading method. JSW was measured at inclusion, 12, 24, and 36 months on radiographs with a postero-anterior, weight-bearing, fixed-flexion acquisition technique. Main secondary endpoints were changes in algofunctional scores (WOMAC), changes in knee pain intensity, and proportion of radiological progressors (patients with knee JSN>0.5 mm). Safety was assessed by adverse events and haematology/biochemistry/haemostasis parameters. Results Detailed results will be presented. The patients were included in 113 centres in 18 countries. 558 patients were assigned to SrRan 1 g/day, 566 to 2 g/day, and 559 to placebo. Mean follow-up was 29.8±10.5 months. Mean age was 62.8±7.2 years and 69% were female. Mean BMI was 30±5 kg/m2, mean JSW was 3.50±0.83 mm, and 61% of randomised patients were Kellgren and Lawrence stage II. Conclusions This large randomised placebo-controlled study will establish the long-term efficacyof SrRan on structure and symptoms in patients with knee osteoarthritis. Disclosure of Interest None Declared</div></front></TEI><istex><corpusName>bmj</corpusName><keywords><teeft><json:string>rheumatology</json:string><json:string>osteoarthritis</json:string><json:string>orthopaedics</json:string><json:string>general practice</json:string><json:string>knee osteoarthritis</json:string><json:string>sint maartenskliniek</json:string><json:string>medical imaging</json:string><json:string>rheumatology unit</json:string><json:string>santa maria</json:string><json:string>public health</json:string><json:string>orthopaedic surgery</json:string><json:string>victor babes</json:string><json:string>centre</json:string></teeft></keywords><author><json:item><name>C. Cooper</name><affiliations><json:string>MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom</json:string><json:string>MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom</json:string></affiliations></json:item><json:item><name>R. Chapurlat</name><affiliations><json:string>INSERM UMR 1033 and Université de Lyon, Hôpital Edouard Herriot, Lyon, France</json:string><json:string>INSERM UMR 1033 and Université de Lyon, Hôpital Edouard Herriot, Lyon, France</json:string></affiliations></json:item><json:item><name>C. Christiansen</name><affiliations><json:string>CCBR Ballerup, Ballerup, Denmark</json:string><json:string>CCBR Ballerup, Ballerup, Denmark</json:string></affiliations></json:item><json:item><name>H. Genant</name><affiliations><json:string>Radiology, Medicine and Orthopaedic Surgery University of California San Francisco, and Synarc, San Francisco, United States</json:string><json:string>Radiology, Medicine and Orthopaedic Surgery University of California San Francisco, and Synarc, San Francisco, United States</json:string></affiliations></json:item><json:item><name>N. Bellamy</name><affiliations><json:string>University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia</json:string><json:string>University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia</json:string></affiliations></json:item><json:item><name>W. Bensen</name><affiliations><json:string>McMaster University Hamilton, Ontario, Canada</json:string><json:string>McMaster University Hamilton, Ontario, Canada</json:string></affiliations></json:item><json:item><name>F. Navarro</name><affiliations><json:string>H. Clinico Virgen de la Macarena Servicio de Reumatologia, Sevilla, Spain</json:string><json:string>H. Clinico Virgen de la Macarena Servicio de Reumatologia, Sevilla, Spain</json:string></affiliations></json:item><json:item><name>J. Badurski</name><affiliations><json:string>Centre of Osteoporosis and Osteo– articular Diseases, Bialystock, Poland</json:string><json:string>Centre of Osteoporosis and Osteo– articular Diseases, Bialystock, Poland</json:string></affiliations></json:item><json:item><name>E. Nasonov</name><affiliations><json:string>State Institute of Rheumatology, the Russian Academy of Medical Sciences, Moscow, Russian Federation</json:string><json:string>State Institute of Rheumatology, the Russian Academy of Medical Sciences, Moscow, Russian Federation</json:string></affiliations></json:item><json:item><name>X. Chevalier</name><affiliations><json:string>Hôpital Henri Mondor, Créteil, France</json:string><json:string>Hôpital Henri Mondor, Créteil, France</json:string></affiliations></json:item><json:item><name>P. Sambrook</name><affiliations><json:string>Royal North Shore Hospital, St. Leonards NSW, Australia</json:string><json:string>Royal North Shore Hospital, St. Leonards NSW, Australia</json:string></affiliations></json:item><json:item><name>T. Spector</name><affiliations><json:string>Kings College London, St Thomas’ Campus, London, United Kingdom</json:string><json:string>Kings College London, St Thomas’ Campus, London, United Kingdom</json:string></affiliations></json:item><json:item><name>J.-Y. Reginster</name><affiliations><json:string>University of Liège, Liège, Belgium</json:string><json:string>University of Liège, Liège, Belgium</json:string></affiliations></json:item></author><articleId><json:string>annrheumdis-2012-eular.962</json:string></articleId><arkIstex>ark:/67375/NVC-4C974FDJ-1</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>abstract</json:string></originalGenre><abstract>Background Strontium ranelate (SrRan) has potential beneficial effects on cartilage degradation in OA, stimulating human cartilage matrix formation in vitro and decreasing the urinary C-terminal telopeptides of type II-collagen. SrRan has also been shown to reduce radiographic spinal OA progression and back pain in osteoporotic women with prevalent spinal OA. Objectives We compared the efficacy and safety of SrRan with placebo in the treatment of knee osteoarthritis in a double-blind, placebo-controlled, randomised, international study (registration number: ISRCTN41323372) designed in accordance with the European Guidelines. Methods Patients with primary knee osteoarthritis, Kellgren and Lawrence grade 2 or 3, joint space width (JSW) 2.5 to 5 mm, and knee pain intensity of at least 40 mm on a visual analogue scale during the month prior to selection, were randomly allocated to SrRan 1 or 2 g/day, or placebo using a centralised interactive voice response system. The primary endpoint was radiographic joint space narrowing measured as the mean change in the minimal JSW of the knee medial tibiofemoral compartment with a semiautomated centralised reading method. JSW was measured at inclusion, 12, 24, and 36 months on radiographs with a postero-anterior, weight-bearing, fixed-flexion acquisition technique. Main secondary endpoints were changes in algofunctional scores (WOMAC), changes in knee pain intensity, and proportion of radiological progressors (patients with knee JSN>0.5 mm). Safety was assessed by adverse events and haematology/biochemistry/haemostasis parameters. Results Detailed results will be presented. The patients were included in 113 centres in 18 countries. 558 patients were assigned to SrRan 1 g/day, 566 to 2 g/day, and 559 to placebo. Mean follow-up was 29.8±10.5 months. Mean age was 62.8±7.2 years and 69% were female. Mean BMI was 30±5 kg/m2, mean JSW was 3.50±0.83 mm, and 61% of randomised patients were Kellgren and Lawrence stage II. Conclusions This large randomised placebo-controlled study will establish the long-term efficacyof SrRan on structure and symptoms in patients with knee osteoarthritis. Disclosure of Interest None Declared</abstract><qualityIndicators><score>5.93</score><pdfWordCount>930</pdfWordCount><pdfCharCount>5791</pdfCharCount><pdfVersion>1.4</pdfVersion><pdfPageCount>1</pdfPageCount><pdfPageSize>595 x 842 pts (A4)</pdfPageSize><refBibsNative>false</refBibsNative><abstractWordCount>317</abstractWordCount><abstractCharCount>2188</abstractCharCount><keywordCount>0</keywordCount></qualityIndicators><title>AB0962 Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: A randomized, double-blind, placebo-controlled international trial</title><genre><json:string>abstract</json:string></genre><host><title>Annals of the Rheumatic Diseases</title><language><json:string>unknown</json:string></language><issn><json:string>0003-4967</json:string></issn><eissn><json:string>1468-2060</json:string></eissn><publisherId><json:string>ard</json:string></publisherId><volume>71</volume><issue>Suppl 3</issue><pages><first>693</first></pages><genre><json:string>journal</json:string></genre><subject><json:item><value>Abstracts accepted for publication</value></json:item><json:item><value>Osteoarthritis</value></json:item></subject></host><namedEntities><unitex><date><json:string>2013</json:string></date><geogName></geogName><orgName><json:string>India, Lucknow, India AB</json:string><json:string>Lund University</json:string><json:string>Radboud University</json:string><json:string>University of Liège</json:string><json:string>Department of Orthopaedic Surgery, CHU, Liège, Belgium AB</json:string><json:string>Italy AB</json:string><json:string>Brazil EFFICACY AND SAFETY OF STRONTIUM RANELATE IN THE TREATMENT OF KNEE OSTEOARTHRITIS</json:string><json:string>University of Alexandria</json:string><json:string>Colombia AB</json:string><json:string>University of Medicine</json:string><json:string>Spenshult Hospital, Oskarström</json:string><json:string>Bone Metabolic Diseases Department, Hospital</json:string><json:string>Women’s Hospital, Herston, Queensland, Australia</json:string><json:string>Karolinska Institute, Huddinge</json:string><json:string>University of Oradea</json:string><json:string>University of Queensland</json:string><json:string>Department of Medical Imaging, Rambam Health Care Campus</json:string><json:string>Romania RADIOLOGICAL AND CLINICAL PROFIL OF OSTEOARTHRITIC PATIENTS UNDERGOING TOTAL JOINT REPLACEMENT A</json:string><json:string>Department of Public Health, University of Liège</json:string><json:string>Orthopaedics Department, Hospital</json:string><json:string>State Institute of Rheumatology, the Russian Academy of Medical Sciences, Moscow, Russian Federation</json:string><json:string>Erasmus University</json:string><json:string>Portugal AB</json:string><json:string>Department of Rheumatology, Skåne University Hospital Malmö, Lund, Sweden Osteoarthritis AB</json:string><json:string>Leiden University</json:string><json:string>Royal North Shore Hospital, St</json:string><json:string>Medical University</json:string><json:string>Shine Department of Rheumatology</json:string><json:string>Belgium AB</json:string><json:string>Netherlands AB</json:string><json:string>Department of Mechanical Engineering, Instituto Superior Técnico</json:string><json:string>Southampton General Hospital, Southampton, United Kingdom</json:string><json:string>Egypt AB</json:string><json:string>Orthopaedic Surgery University</json:string><json:string>University of Perugia</json:string><json:string>Rheumatology Research Unit, Instituto</json:string></orgName><orgName_funder></orgName_funder><orgName_provider></orgName_provider><persName><json:string>I.B. Cruz</json:string><json:string>R. Fuller</json:string><json:string>R. Traistaru</json:string><json:string>E. Bartoloni</json:string><json:string>A. Bighea</json:string><json:string>N.H. Yoshinari</json:string><json:string>W. Bensen</json:string><json:string>H. Genant</json:string><json:string>J. Monteiro</json:string><json:string>A. Neuprez</json:string><json:string>A. Sepriano</json:string><json:string>A.M. Lurati</json:string><json:string>S. Abou-Raya</json:string><json:string>C. Cooper</json:string><json:string>Y. Reginster</json:string><json:string>Victor Babes</json:string><json:string>C. van den Ende</json:string><json:string>X. Chevalier</json:string><json:string>S. Momi</json:string><json:string>M.G. Marrazza</json:string><json:string>J. Badurski</json:string><json:string>M.I. Cevei</json:string><json:string>B. Vidal</json:string><json:string>T. El Khadrawy</json:string><json:string>W. Kurth</json:string><json:string>A. Balbir-Gurman</json:string><json:string>A.P. 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Romeu</json:string><json:string>V. Capelozzi</json:string><json:string>F. Luccioli</json:string><json:string>S. Patru</json:string><json:string>L. Bertani</json:string><json:string>Henri Mondor</json:string><json:string>B. Swierstra</json:string><json:string>J. Kortland</json:string><json:string>P. Gresele</json:string><json:string>F. Bonilla-Abadía</json:string><json:string>K.A. Re</json:string><json:string>S. Carrasco</json:string><json:string>D. Bompane</json:string><json:string>M. Scarpellini</json:string><json:string>A. Faustino</json:string><json:string>A. Alunno</json:string><json:string>D. Nemes</json:string><json:string>A.M. Rodrigues</json:string><json:string>Santa Maria</json:string><json:string>W.R. Teodoro</json:string><json:string>G. François</json:string><json:string>N. Coronel</json:string><json:string>A.C. Vale</json:string><json:string>M.C. Cepeda</json:string><json:string>J. Dekker</json:string><json:string>H. Bijlsma</json:string><json:string>P. Sambrook</json:string><json:string>R.N. Srivastava</json:string><json:string>C. Christiansen</json:string><json:string>C. Cañas</json:string><json:string>A. Singh</json:string><json:string>J.A. Pereira</json:string><json:string>O. Bistoni</json:string><json:string>T. Spector</json:string><json:string>N. Bellamy</json:string><json:string>J. Caetano-Lopes</json:string><json:string>T. Thirion</json:string><json:string>J.H. Izquierdo</json:string><json:string>G. Santoboni</json:string><json:string>S. Bierma-Zeinstra</json:string><json:string>V. Kovats</json:string><json:string>H. Clinico</json:string></persName><placeName><json:string>Leiden</json:string><json:string>Utrecht</json:string><json:string>Brisbane</json:string><json:string>United States</json:string><json:string>St Thomas</json:string><json:string>Perugia</json:string><json:string>Australia</json:string><json:string>Oradea</json:string><json:string>Poland</json:string><json:string>Canada</json:string><json:string>Romania</json:string><json:string>London</json:string><json:string>Haifa</json:string><json:string>Nijmegen</json:string><json:string>Lisbon</json:string><json:string>San Francisco</json:string><json:string>Amsterdam</json:string><json:string>Denmark</json:string><json:string>Amersfoort</json:string><json:string>Rotterdam</json:string><json:string>United Kingdom</json:string><json:string>Israel</json:string><json:string>France</json:string><json:string>Sao Paulo</json:string><json:string>Spain</json:string><json:string>Lyon</json:string><json:string>Craiova</json:string></placeName><ref_url></ref_url><ref_bibl></ref_bibl><bibl></bibl></unitex></namedEntities><ark><json:string>ark:/67375/NVC-4C974FDJ-1</json:string></ark><categories><wos><json:string>1 - science</json:string><json:string>2 - rheumatology</json:string></wos><scienceMetrix><json:string>1 - health sciences</json:string><json:string>2 - clinical medicine</json:string><json:string>3 - arthritis & rheumatology</json:string></scienceMetrix><scopus><json:string>1 - Life Sciences</json:string><json:string>2 - Biochemistry, Genetics and Molecular Biology</json:string><json:string>3 - General Biochemistry, Genetics and Molecular Biology</json:string><json:string>1 - Life Sciences</json:string><json:string>2 - Immunology and Microbiology</json:string><json:string>3 - Immunology</json:string><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Immunology and Allergy</json:string><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Rheumatology</json:string></scopus><inist><json:string>1 - sciences appliquees, technologies et medecines</json:string><json:string>2 - sciences biologiques et medicales</json:string><json:string>3 - sciences medicales</json:string></inist></categories><publicationDate>2013</publicationDate><copyrightDate>2013</copyrightDate><doi><json:string>10.1136/annrheumdis-2012-eular.962</json:string></doi><id>DE63D260B906D9D4CC4E1468247F78DA72563F50</id><score>1</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/DE63D260B906D9D4CC4E1468247F78DA72563F50/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/DE63D260B906D9D4CC4E1468247F78DA72563F50/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/DE63D260B906D9D4CC4E1468247F78DA72563F50/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">AB0962 Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: A randomized, double-blind, placebo-controlled international trial</title><respStmt><resp>Références bibliographiques récupérées via GROBID</resp><name resp="ISTEX-API">ISTEX-API (INIST-CNRS)</name></respStmt></titleStmt><publicationStmt><authority>ISTEX</authority><publisher scheme="https://publisher-list.data.istex.fr">BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><availability><licence><p>© 2013, 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</p></licence><p scheme="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-7M42M2QJ-2">bmj</p></availability><date>2013</date></publicationStmt><notesStmt><note type="abstract" scheme="https://content-type.data.istex.fr/ark:/67375/XTP-HPN7T1Q2-R">abstract</note><note type="journal" scheme="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">AB0962 Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: A randomized, double-blind, placebo-controlled international trial</title><author xml:id="author-0000"><persName><forename type="first">C.</forename><surname>Cooper</surname></persName><affiliation>MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom</affiliation><affiliation>MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom</affiliation></author><author xml:id="author-0001"><persName><forename type="first">R.</forename><surname>Chapurlat</surname></persName><affiliation>INSERM UMR 1033 and Université de Lyon, Hôpital Edouard Herriot, Lyon, France</affiliation><affiliation>INSERM UMR 1033 and Université de Lyon, Hôpital Edouard Herriot, Lyon, France</affiliation></author><author xml:id="author-0002"><persName><forename type="first">C.</forename><surname>Christiansen</surname></persName><affiliation>CCBR Ballerup, Ballerup, Denmark</affiliation><affiliation>CCBR Ballerup, Ballerup, Denmark</affiliation></author><author xml:id="author-0003"><persName><forename type="first">H.</forename><surname>Genant</surname></persName><affiliation>Radiology, Medicine and Orthopaedic Surgery University of California San Francisco, and Synarc, San Francisco, United States</affiliation><affiliation>Radiology, Medicine and Orthopaedic Surgery University of California San Francisco, and Synarc, San Francisco, United States</affiliation></author><author xml:id="author-0004"><persName><forename type="first">N.</forename><surname>Bellamy</surname></persName><affiliation>University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia</affiliation><affiliation>University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia</affiliation></author><author xml:id="author-0005"><persName><forename type="first">W.</forename><surname>Bensen</surname></persName><affiliation>McMaster University Hamilton, Ontario, Canada</affiliation><affiliation>McMaster University Hamilton, Ontario, Canada</affiliation></author><author xml:id="author-0006"><persName><forename type="first">F.</forename><surname>Navarro</surname></persName><affiliation>H. Clinico Virgen de la Macarena Servicio de Reumatologia, Sevilla, Spain</affiliation><affiliation>H. Clinico Virgen de la Macarena Servicio de Reumatologia, Sevilla, Spain</affiliation></author><author xml:id="author-0007"><persName><forename type="first">J.</forename><surname>Badurski</surname></persName><affiliation>Centre of Osteoporosis and Osteo– articular Diseases, Bialystock, Poland</affiliation><affiliation>Centre of Osteoporosis and Osteo– articular Diseases, Bialystock, Poland</affiliation></author><author xml:id="author-0008"><persName><forename type="first">E.</forename><surname>Nasonov</surname></persName><affiliation>State Institute of Rheumatology, the Russian Academy of Medical Sciences, Moscow, Russian Federation</affiliation><affiliation>State Institute of Rheumatology, the Russian Academy of Medical Sciences, Moscow, Russian Federation</affiliation></author><author xml:id="author-0009"><persName><forename type="first">X.</forename><surname>Chevalier</surname></persName><affiliation>Hôpital Henri Mondor, Créteil, France</affiliation><affiliation>Hôpital Henri Mondor, Créteil, France</affiliation></author><author xml:id="author-0010"><persName><forename type="first">P.</forename><surname>Sambrook</surname></persName><affiliation>Royal North Shore Hospital, St. Leonards NSW, Australia</affiliation><affiliation>Royal North Shore Hospital, St. Leonards NSW, Australia</affiliation></author><author xml:id="author-0011"><persName><forename type="first">T.</forename><surname>Spector</surname></persName><affiliation>Kings College London, St Thomas’ Campus, London, United Kingdom</affiliation><affiliation>Kings College London, St Thomas’ Campus, London, United Kingdom</affiliation></author><author xml:id="author-0012"><persName><forename type="first">J.-Y.</forename><surname>Reginster</surname></persName><affiliation>University of Liège, Liège, Belgium</affiliation><affiliation>University of Liège, Liège, Belgium</affiliation></author><idno type="istex">DE63D260B906D9D4CC4E1468247F78DA72563F50</idno><idno type="ark">ark:/67375/NVC-4C974FDJ-1</idno><idno type="DOI">10.1136/annrheumdis-2012-eular.962</idno><idno type="href">annrheumdis-71-693-13.pdf</idno><idno type="article-id">annrheumdis-2012-eular.962</idno><idno type="local">annrheumdis;71/Suppl_3/693-m</idno></analytic><monogr><title level="j">Annals of the Rheumatic Diseases</title><title level="j" type="abbrev">Ann Rheum Dis</title><idno type="pISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><idno type="publisher-id">ard</idno><idno type="PublisherID-hwp">annrheumdis</idno><idno type="PublisherID-nlm-ta">Ann Rheum Dis</idno><imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><date type="published" when="2013-06"></date><biblScope unit="volume">71</biblScope><biblScope unit="issue">Suppl 3</biblScope><biblScope unit="page" from="693">693</biblScope></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2013</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Background Strontium ranelate (SrRan) has potential beneficial effects on cartilage degradation in OA, stimulating human cartilage matrix formation in vitro and decreasing the urinary C-terminal telopeptides of type II-collagen. SrRan has also been shown to reduce radiographic spinal OA progression and back pain in osteoporotic women with prevalent spinal OA. Objectives We compared the efficacy and safety of SrRan with placebo in the treatment of knee osteoarthritis in a double-blind, placebo-controlled, randomised, international study (registration number: ISRCTN41323372) designed in accordance with the European Guidelines. Methods Patients with primary knee osteoarthritis, Kellgren and Lawrence grade 2 or 3, joint space width (JSW) 2.5 to 5 mm, and knee pain intensity of at least 40 mm on a visual analogue scale during the month prior to selection, were randomly allocated to SrRan 1 or 2 g/day, or placebo using a centralised interactive voice response system. The primary endpoint was radiographic joint space narrowing measured as the mean change in the minimal JSW of the knee medial tibiofemoral compartment with a semiautomated centralised reading method. JSW was measured at inclusion, 12, 24, and 36 months on radiographs with a postero-anterior, weight-bearing, fixed-flexion acquisition technique. Main secondary endpoints were changes in algofunctional scores (WOMAC), changes in knee pain intensity, and proportion of radiological progressors (patients with knee JSN>0.5 mm). Safety was assessed by adverse events and haematology/biochemistry/haemostasis parameters. Results Detailed results will be presented. The patients were included in 113 centres in 18 countries. 558 patients were assigned to SrRan 1 g/day, 566 to 2 g/day, and 559 to placebo. Mean follow-up was 29.8±10.5 months. Mean age was 62.8±7.2 years and 69% were female. Mean BMI was 30±5 kg/m2, mean JSW was 3.50±0.83 mm, and 61% of randomised patients were Kellgren and Lawrence stage II. Conclusions This large randomised placebo-controlled study will establish the long-term efficacyof SrRan on structure and symptoms in patients with knee osteoarthritis. Disclosure of Interest None Declared</p></abstract><textClass><keywords scheme="Journal Subject"><list><head></head><item><term>Abstracts accepted for publication</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head></head><item><term>Osteoarthritis</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2013-06">Published</change><change xml:id="refBibs-istex" who="#ISTEX-API" when="2017-10-17">References added</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/DE63D260B906D9D4CC4E1468247F78DA72563F50/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus bmj" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="no"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Archiving and Interchange DTD v2.3 20070202//EN" URI="archivearticle.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="abstract" xml:lang="EN"><front><journal-meta><journal-id journal-id-type="hwp">annrheumdis</journal-id><journal-id journal-id-type="nlm-ta">Ann Rheum Dis</journal-id><journal-id journal-id-type="publisher-id">ard</journal-id><journal-title>Annals of the Rheumatic Diseases</journal-title><abbrev-journal-title abbrev-type="publisher">Ann Rheum Dis</abbrev-journal-title><abbrev-journal-title>Ann Rheum Dis</abbrev-journal-title><issn pub-type="ppub">0003-4967</issn><issn pub-type="epub">1468-2060</issn><publisher><publisher-name>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">annrheumdis-2012-eular.962</article-id><article-id pub-id-type="doi">10.1136/annrheumdis-2012-eular.962</article-id><article-id pub-id-type="other">annrheumdis;71/Suppl_3/693-m</article-id><article-id pub-id-type="other">annrheumdis;annrheumdis-2012-eular.962</article-id><article-id pub-id-type="other">693.13</article-id><article-id pub-id-type="other">annrheumdis-2012-eular.962</article-id><article-categories><subj-group subj-group-type="heading"><subject>Scientific Abstracts</subject><subj-group><subject>Abstracts accepted for publication</subject><subj-group><subject>Osteoarthritis</subject></subj-group></subj-group></subj-group></article-categories><title-group><article-title>AB0962 Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: A randomized, double-blind, placebo-controlled international trial</article-title></title-group><contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Cooper</surname><given-names>C.</given-names></name><xref ref-type="aff" rid="AFF_1"><sup>1</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Chapurlat</surname><given-names>R.</given-names></name><xref ref-type="aff" rid="AFF_2"><sup>2</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Christiansen</surname><given-names>C.</given-names></name><xref ref-type="aff" rid="AFF_3"><sup>3</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Genant</surname><given-names>H.</given-names></name><xref ref-type="aff" rid="AFF_4"><sup>4</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Bellamy</surname><given-names>N.</given-names></name><xref ref-type="aff" rid="AFF_5"><sup>5</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Bensen</surname><given-names>W.</given-names></name><xref ref-type="aff" rid="AFF_6"><sup>6</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Navarro</surname><given-names>F.</given-names></name><xref ref-type="aff" rid="AFF_7"><sup>7</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Badurski</surname><given-names>J.</given-names></name><xref ref-type="aff" rid="AFF_8"><sup>8</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Nasonov</surname><given-names>E.</given-names></name><xref ref-type="aff" rid="AFF_9"><sup>9</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Chevalier</surname><given-names>X.</given-names></name><xref ref-type="aff" rid="AFF_10"><sup>10</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Sambrook</surname><given-names>P.</given-names></name><xref ref-type="aff" rid="AFF_11"><sup>11</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Spector</surname><given-names>T.</given-names></name><xref ref-type="aff" rid="AFF_12"><sup>12</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Reginster</surname><given-names>J.-Y.</given-names></name><xref ref-type="aff" rid="AFF_13"><sup>13</sup></xref></contrib></contrib-group><aff id="AFF_1"><sup>1</sup>MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom
</aff><aff id="AFF_2"><sup>2</sup>INSERM UMR 1033 and Université de Lyon, Hôpital Edouard Herriot, Lyon, France
</aff><aff id="AFF_3"><sup>3</sup>CCBR Ballerup, Ballerup, Denmark
</aff><aff id="AFF_4"><sup>4</sup>Radiology, Medicine and Orthopaedic Surgery University of California San Francisco, and Synarc, San Francisco, United States
</aff><aff id="AFF_5"><sup>5</sup>University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia
</aff><aff id="AFF_6"><sup>6</sup>McMaster University Hamilton, Ontario, Canada
</aff><aff id="AFF_7"><sup>7</sup>H. Clinico Virgen de la Macarena Servicio de Reumatologia, Sevilla, Spain
</aff><aff id="AFF_8"><sup>8</sup>Centre of Osteoporosis and Osteo– articular Diseases, Bialystock, Poland
</aff><aff id="AFF_9"><sup>9</sup>State Institute of Rheumatology, the Russian Academy of Medical Sciences, Moscow, Russian Federation
</aff><aff id="AFF_10"><sup>10</sup>Hôpital Henri Mondor, Créteil, France
</aff><aff id="AFF_11"><sup>11</sup>Royal North Shore Hospital, St. Leonards NSW, Australia
</aff><aff id="AFF_12"><sup>12</sup>Kings College London, St Thomas’ Campus, London, United Kingdom
</aff><aff id="AFF_13"><sup>13</sup>University of Liège, Liège, Belgium
</aff><pub-date pub-type="ppub"><month>6</month><year>2013</year></pub-date><volume>71</volume><volume-id pub-id-type="other">71</volume-id><volume-id pub-id-type="other">71</volume-id><issue>Suppl 3</issue><issue-id pub-id-type="other">annrheumdis;71/Suppl_3</issue-id><issue-id pub-id-type="other" content-type="supplement">Suppl_3</issue-id><issue-id pub-id-type="other">71/Suppl_3</issue-id><issue-title>Annual European Congress of Rheumatology EULAR abstracts 2012, 6 – 9 June 2012, Berlin, Germany</issue-title><fpage seq="13">693</fpage><permissions><copyright-statement>© 2013, 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></permissions><self-uri content-type="pdf" xlink:role="full-text" xlink:href="annrheumdis-71-693-13.pdf"></self-uri><abstract><sec><title>Background</title><p>Strontium ranelate (SrRan) has potential beneficial effects on cartilage degradation in OA, stimulating human cartilage matrix formation in vitro and decreasing the urinary C-terminal telopeptides of type II-collagen. SrRan has also been shown to reduce radiographic spinal OA progression and back pain in osteoporotic women with prevalent spinal OA.</p></sec><sec><title>Objectives</title><p>We compared the efficacy and safety of SrRan with placebo in the treatment of knee osteoarthritis in a double-blind, placebo-controlled, randomised, international study (registration number: <ext-link ext-link-type="isrctn" xlink:href="41323372">ISRCTN41323372</ext-link>) designed in accordance with the European Guidelines.</p></sec><sec><title>Methods</title><p>Patients with primary knee osteoarthritis, Kellgren and Lawrence grade 2 or 3, joint space width (JSW) 2.5 to 5 mm, and knee pain intensity of at least 40 mm on a visual analogue scale during the month prior to selection, were randomly allocated to SrRan 1 or 2 g/day, or placebo using a centralised interactive voice response system. The primary endpoint was radiographic joint space narrowing measured as the mean change in the minimal JSW of the knee medial tibiofemoral compartment with a semiautomated centralised reading method. JSW was measured at inclusion, 12, 24, and 36 months on radiographs with a postero-anterior, weight-bearing, fixed-flexion acquisition technique. Main secondary endpoints were changes in algofunctional scores (WOMAC), changes in knee pain intensity, and proportion of radiological progressors (patients with knee JSN>0.5 mm). Safety was assessed by adverse events and haematology/biochemistry/haemostasis parameters.</p></sec><sec><title>Results</title><p>Detailed results will be presented. The patients were included in 113 centres in 18 countries. 558 patients were assigned to SrRan 1 g/day, 566 to 2 g/day, and 559 to placebo. Mean follow-up was 29.8±10.5 months. Mean age was 62.8±7.2 years and 69% were female. Mean BMI was 30±5 kg/m<sup>2</sup>, mean JSW was 3.50±0.83 mm, and 61% of randomised patients were Kellgren and Lawrence stage II.</p></sec><sec><title>Conclusions</title><p>This large randomised placebo-controlled study will establish the long-term efficacyof SrRan on structure and symptoms in patients with knee osteoarthritis.</p></sec><sec><title>Disclosure of Interest</title><p>None Declared</p></sec></abstract></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>AB0962 Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: A randomized, double-blind, placebo-controlled international trial</title></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>AB0962 Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: A randomized, double-blind, placebo-controlled international trial</title></titleInfo><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Cooper</namePart><affiliation>MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom</affiliation><affiliation>MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R.</namePart><namePart type="family">Chapurlat</namePart><affiliation>INSERM UMR 1033 and Université de Lyon, Hôpital Edouard Herriot, Lyon, France</affiliation><affiliation>INSERM UMR 1033 and Université de Lyon, Hôpital Edouard Herriot, Lyon, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Christiansen</namePart><affiliation>CCBR Ballerup, Ballerup, Denmark</affiliation><affiliation>CCBR Ballerup, Ballerup, Denmark</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Genant</namePart><affiliation>Radiology, Medicine and Orthopaedic Surgery University of California San Francisco, and Synarc, San Francisco, United States</affiliation><affiliation>Radiology, Medicine and Orthopaedic Surgery University of California San Francisco, and Synarc, San Francisco, United States</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">N.</namePart><namePart type="family">Bellamy</namePart><affiliation>University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia</affiliation><affiliation>University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">W.</namePart><namePart type="family">Bensen</namePart><affiliation>McMaster University Hamilton, Ontario, Canada</affiliation><affiliation>McMaster University Hamilton, Ontario, Canada</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">F.</namePart><namePart type="family">Navarro</namePart><affiliation>H. Clinico Virgen de la Macarena Servicio de Reumatologia, Sevilla, Spain</affiliation><affiliation>H. Clinico Virgen de la Macarena Servicio de Reumatologia, Sevilla, Spain</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Badurski</namePart><affiliation>Centre of Osteoporosis and Osteo– articular Diseases, Bialystock, Poland</affiliation><affiliation>Centre of Osteoporosis and Osteo– articular Diseases, Bialystock, Poland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">E.</namePart><namePart type="family">Nasonov</namePart><affiliation>State Institute of Rheumatology, the Russian Academy of Medical Sciences, Moscow, Russian Federation</affiliation><affiliation>State Institute of Rheumatology, the Russian Academy of Medical Sciences, Moscow, Russian Federation</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">X.</namePart><namePart type="family">Chevalier</namePart><affiliation>Hôpital Henri Mondor, Créteil, France</affiliation><affiliation>Hôpital Henri Mondor, Créteil, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.</namePart><namePart type="family">Sambrook</namePart><affiliation>Royal North Shore Hospital, St. Leonards NSW, Australia</affiliation><affiliation>Royal North Shore Hospital, St. Leonards NSW, Australia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">T.</namePart><namePart type="family">Spector</namePart><affiliation>Kings College London, St Thomas’ Campus, London, United Kingdom</affiliation><affiliation>Kings College London, St Thomas’ Campus, London, United Kingdom</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.-Y.</namePart><namePart type="family">Reginster</namePart><affiliation>University of Liège, Liège, Belgium</affiliation><affiliation>University of Liège, Liège, Belgium</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="abstract" displayLabel="abstract" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-HPN7T1Q2-R">abstract</genre><originInfo><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><dateIssued encoding="w3cdtf">2013-06</dateIssued><copyrightDate encoding="w3cdtf">2013</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><abstract>Background Strontium ranelate (SrRan) has potential beneficial effects on cartilage degradation in OA, stimulating human cartilage matrix formation in vitro and decreasing the urinary C-terminal telopeptides of type II-collagen. SrRan has also been shown to reduce radiographic spinal OA progression and back pain in osteoporotic women with prevalent spinal OA. Objectives We compared the efficacy and safety of SrRan with placebo in the treatment of knee osteoarthritis in a double-blind, placebo-controlled, randomised, international study (registration number: ISRCTN41323372) designed in accordance with the European Guidelines. Methods Patients with primary knee osteoarthritis, Kellgren and Lawrence grade 2 or 3, joint space width (JSW) 2.5 to 5 mm, and knee pain intensity of at least 40 mm on a visual analogue scale during the month prior to selection, were randomly allocated to SrRan 1 or 2 g/day, or placebo using a centralised interactive voice response system. The primary endpoint was radiographic joint space narrowing measured as the mean change in the minimal JSW of the knee medial tibiofemoral compartment with a semiautomated centralised reading method. JSW was measured at inclusion, 12, 24, and 36 months on radiographs with a postero-anterior, weight-bearing, fixed-flexion acquisition technique. Main secondary endpoints were changes in algofunctional scores (WOMAC), changes in knee pain intensity, and proportion of radiological progressors (patients with knee JSN>0.5 mm). Safety was assessed by adverse events and haematology/biochemistry/haemostasis parameters. Results Detailed results will be presented. The patients were included in 113 centres in 18 countries. 558 patients were assigned to SrRan 1 g/day, 566 to 2 g/day, and 559 to placebo. Mean follow-up was 29.8±10.5 months. Mean age was 62.8±7.2 years and 69% were female. Mean BMI was 30±5 kg/m2, mean JSW was 3.50±0.83 mm, and 61% of randomised patients were Kellgren and Lawrence stage II. Conclusions This large randomised placebo-controlled study will establish the long-term efficacyof SrRan on structure and symptoms in patients with knee osteoarthritis. Disclosure of Interest None Declared</abstract><relatedItem type="host"><titleInfo><title>Annals of the Rheumatic Diseases</title></titleInfo><titleInfo type="abbreviated"><title>Ann Rheum Dis</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><subject><topic>Abstracts accepted for publication</topic></subject><subject><topic>Osteoarthritis</topic></subject><identifier type="ISSN">0003-4967</identifier><identifier type="eISSN">1468-2060</identifier><identifier type="PublisherID">ard</identifier><identifier type="PublisherID-hwp">annrheumdis</identifier><identifier type="PublisherID-nlm-ta">Ann Rheum Dis</identifier><part><date>2013</date><detail type="title"><title>Annual European Congress of Rheumatology EULAR abstracts 2012, 6 – 9 June 2012, Berlin, Germany</title></detail><detail type="volume"><caption>vol.</caption><number>71</number></detail><detail type="issue"><caption>no.</caption><number>Suppl 3</number></detail><extent unit="pages"><start>693</start></extent></part></relatedItem><identifier type="istex">DE63D260B906D9D4CC4E1468247F78DA72563F50</identifier><identifier type="ark">ark:/67375/NVC-4C974FDJ-1</identifier><identifier type="DOI">10.1136/annrheumdis-2012-eular.962</identifier><identifier type="href">annrheumdis-71-693-13.pdf</identifier><identifier type="ArticleID">annrheumdis-2012-eular.962</identifier><identifier type="local">annrheumdis;71/Suppl_3/693-m</identifier><accessCondition type="use and reproduction" contentType="copyright">© 2013, Published by the BMJ Publishing Group Limited. 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