Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial
Identifieur interne : 004900 ( Main/Exploration ); précédent : 004899; suivant : 004901Efficacy 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 ] ; 2013-02.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : épidémiologie.
English descriptors
- KwdEn :
- Advisory boards, Baseline, Cartilage, Chondroitin, Chondroitin sulphate, Consulting fees, Epidemiological, Epidemiological research, Epidemiology, Executive committee, Function subscore, Global knee pain, Glucosamine, Glucosamine sulphate, Health economics, Joint space, Joint space width, Knee, Knee osteoarthritis, Knee pain, Lawrence grade, Liege, Mcmaster universities osteoarthritis index, Medial tibiofemoral compartment, Osteoarthritis, Osteoporosis, Pain subscore, Placebo, Postmenopausal osteoporosis, Primary endpoint, Progression, Public health epidemiology, Radioclinical, Radioclinical progression, Radioclinical progressors, Radiological, Radiological progression, Randomised, Randomised patients, Ranelate, Relevant differences, Rheum, Rheumatology, Sensitivity analyses, Strontium, Strontium ranelate, Subchondral, Subchondral bone, Subscore, Sulphate, Target knee, Total womac score, Toxicity, Treatment, Treatment allocation, Treatment groups, Visual analogue scale, Western ontario, Womac, Womac pain.
- Teeft :
- Advisory boards, Baseline, Cartilage, Chondroitin, Chondroitin sulphate, Consulting fees, Epidemiological, Epidemiological research, Epidemiology, Executive committee, Function subscore, Global knee pain, Glucosamine, Glucosamine sulphate, Health economics, Joint space, Joint space width, Knee osteoarthritis, Knee pain, Lawrence grade, Liege, Mcmaster universities osteoarthritis index, Medial tibiofemoral compartment, Osteoarthritis, Osteoporosis, Pain subscore, Placebo, Postmenopausal osteoporosis, Primary endpoint, Progression, Public health epidemiology, Radioclinical, Radioclinical progression, Radioclinical progressors, Radiological, Radiological progression, Randomised, Randomised patients, Ranelate, Relevant differences, Rheum, Sensitivity analyses, Strontium, Strontium ranelate, Subchondral, Subchondral bone, Subscore, Sulphate, Target knee, Total womac score, Treatment allocation, Treatment groups, Visual analogue scale, Western ontario, Womac, Womac pain.
Abstract
Background 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. Methods 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). Results 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. Conclusions 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:
- https://api.istex.fr/document/E670E68E92DACB168D91C6D35877E13418AF5013/fulltext/pdf
- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3599139
DOI: 10.1136/annrheumdis-2012-202231
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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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"><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"><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"><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><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="2013-02">2013-02</date><biblScope unit="volume">72</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="179">179</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>Advisory boards</term><term>Baseline</term><term>Cartilage</term><term>Chondroitin</term><term>Chondroitin sulphate</term><term>Consulting fees</term><term>Epidemiological</term><term>Epidemiological research</term><term>Epidemiology</term><term>Executive committee</term><term>Function subscore</term><term>Global knee pain</term><term>Glucosamine</term><term>Glucosamine sulphate</term><term>Health economics</term><term>Joint space</term><term>Joint space width</term><term>Knee</term><term>Knee osteoarthritis</term><term>Knee pain</term><term>Lawrence grade</term><term>Liege</term><term>Mcmaster universities osteoarthritis index</term><term>Medial tibiofemoral compartment</term><term>Osteoarthritis</term><term>Osteoporosis</term><term>Pain subscore</term><term>Placebo</term><term>Postmenopausal osteoporosis</term><term>Primary endpoint</term><term>Progression</term><term>Public health epidemiology</term><term>Radioclinical</term><term>Radioclinical progression</term><term>Radioclinical progressors</term><term>Radiological</term><term>Radiological progression</term><term>Randomised</term><term>Randomised patients</term><term>Ranelate</term><term>Relevant differences</term><term>Rheum</term><term>Rheumatology</term><term>Sensitivity analyses</term><term>Strontium</term><term>Strontium ranelate</term><term>Subchondral</term><term>Subchondral bone</term><term>Subscore</term><term>Sulphate</term><term>Target knee</term><term>Total womac score</term><term>Toxicity</term><term>Treatment</term><term>Treatment allocation</term><term>Treatment groups</term><term>Visual analogue scale</term><term>Western ontario</term><term>Womac</term><term>Womac pain</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Arthrose</term><term>Genou</term><term>Gonarthrose</term><term>Ranélate de strontium</term><term>Rhumatologie</term><term>Toxicité</term><term>Traitement</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Advisory boards</term><term>Baseline</term><term>Cartilage</term><term>Chondroitin</term><term>Chondroitin sulphate</term><term>Consulting fees</term><term>Epidemiological</term><term>Epidemiological research</term><term>Epidemiology</term><term>Executive committee</term><term>Function subscore</term><term>Global knee pain</term><term>Glucosamine</term><term>Glucosamine sulphate</term><term>Health economics</term><term>Joint space</term><term>Joint space width</term><term>Knee osteoarthritis</term><term>Knee pain</term><term>Lawrence grade</term><term>Liege</term><term>Mcmaster universities osteoarthritis index</term><term>Medial tibiofemoral compartment</term><term>Osteoarthritis</term><term>Osteoporosis</term><term>Pain subscore</term><term>Placebo</term><term>Postmenopausal osteoporosis</term><term>Primary endpoint</term><term>Progression</term><term>Public health epidemiology</term><term>Radioclinical</term><term>Radioclinical progression</term><term>Radioclinical progressors</term><term>Radiological</term><term>Radiological progression</term><term>Randomised</term><term>Randomised patients</term><term>Ranelate</term><term>Relevant differences</term><term>Rheum</term><term>Sensitivity analyses</term><term>Strontium</term><term>Strontium ranelate</term><term>Subchondral</term><term>Subchondral bone</term><term>Subscore</term><term>Sulphate</term><term>Target knee</term><term>Total womac score</term><term>Treatment allocation</term><term>Treatment groups</term><term>Visual analogue scale</term><term>Western ontario</term><term>Womac</term><term>Womac pain</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>épidémiologie</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Background 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. Methods 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). Results 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. Conclusions 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.</div></front></TEI><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. Spector</name></region><name sortKey="Cooper, Cyrus" sort="Cooper, Cyrus" uniqKey="Cooper C" first="Cyrus" last="Cooper">Cyrus Cooper</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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