Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial
Identifieur interne : 000056 ( France/Analysis ); précédent : 000055; suivant : 000057Efficacy 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.
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:
DOI: 10.1136/annrheumdis-2012-202231
Affiliations:
- Australie, Belgique, Canada, Danemark, Espagne, France, Pologne, Royaume-Uni, Russie, États-Unis
- Angleterre, Californie, District fédéral central, Grand Londres, Oxfordshire
- Créteil, Londres, Lyon, Moscou, Oxford
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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>Californie</li><li>District fédéral central</li><li>Grand Londres</li><li>Oxfordshire</li></region><settlement><li>Créteil</li><li>Londres</li><li>Lyon</li><li>Moscou</li><li>Oxford</li></settlement></list><tree><country name="Belgique"><noRegion><name sortKey="Reginster, Jean Yves" sort="Reginster, Jean Yves" uniqKey="Reginster J" first="Jean-Yves" last="Reginster">Jean-Yves Reginster</name></noRegion></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"><noRegion><name sortKey="Chapurlat, Roland" sort="Chapurlat, Roland" uniqKey="Chapurlat R" first="Roland" last="Chapurlat">Roland Chapurlat</name></noRegion><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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