期刊
ANNALS OF THE RHEUMATIC DISEASES
卷 72, 期 2, 页码 179-186出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/annrheumdis-2012-202231
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资金
- Servier, France
- Novartis
- Negma
- Lilly
- Wyeth
- Amgen
- GlaxoSmithKline
- Roche
- Merckle
- Nycomed
- NPS
- Theramex
- UCB
- Merck Sharp and Dohme
- Rottapharm
- IBSA
- Genevrier
- Teijin
- Teva
- Ebewee Pharma
- Zodiac
- Analis
- Novo-Nordisk
- Bristol Myers Squibb
- GSK
- BMS
- Pfizer
- Merck
- Ono Pharma
- Expanscience
- MSD
- Alliance for Better Bone Health
- Glaxo Smith Kline
- MRC [MC_U147585819, G0400491, MC_U147585827] Funding Source: UKRI
- Medical Research Council [U1475000001, MC_U147585819, G0400491, MC_UU_12011/1, MC_UP_A620_1014, MC_U147585827, MC_U147585824] Funding Source: researchfish
- National Institute for Health Research [NF-SI-0508-10082] Funding Source: researchfish
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.
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