Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial.
Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial.
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DOI：
10.1136/annrheumdis-2012-202231
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发表时间：
2013-02
影响因子：
27.4
通讯作者：
Cooper C
中科院分区：
文献类型：
--
作者：
Reginster JY;Badurski J;Bellamy N;Bensen W;Chapurlat R;Chevalier X;Christiansen C;Genant H;Navarro F;Nasonov E;Sambrook PN;Spector TD;Cooper C
雷奈酸锶目前用于治疗骨质疏松症。国际、双盲、随机、安慰剂对照雷奈酸锶治疗膝关节骨关节炎疗效试验评价了其对膝关节骨关节炎放射学进展的影响。膝骨关节炎患者（Kellgren和Lawrence分级2或3级，关节间隙宽度（JSW）2.5-5 mm）随机分配至雷奈酸锶1 g/天组（n=558）、2 g/天组（n=566）或安慰剂组（n=559）。 主要终点是与安慰剂相比，3年内JSW（内侧胫股间室）的影像学变化。 次要终点包括放射学进展、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分和膝关节疼痛。该试验已注册（ISRCTN 41323372）。意向治疗人群包括1371例患者。与安慰剂相比，雷奈酸锶治疗与JSW的较小降解相关（1 g/天：-0.23（SD 0.56）mm; 2 g/天：-0.27（SD 0.63）mm;安慰剂：-0.37（SD 0.59）mm）;治疗-安慰剂差异为0.14（SE 0.04），95% CI 0.05至0.23，p<0.001（1 g/天）和0.10（SE 0.04），95% CI 0.02至0.19，p=0.018（2 g/天）。 雷奈酸锶组的放射学进展较少（1和2 g/天组p<0.001和p=0.012）。 雷奈酸锶2 g/天组的WOMAC总分（p=0.045）、疼痛分项评分（p=0.028）、身体功能分项评分（p=0.099）和膝关节疼痛（p=0.065）降低幅度更大。 雷奈酸锶耐受性良好。雷奈酸锶1和2 g/天的治疗与膝关节骨关节炎患者的结构显著影响相关，雷奈酸锶2 g/天对症状有益。
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.
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影响因子：
27.4
作者：
CLAESSENS, AAMC;SCHOUTEN, JSAG;VALKENBURG, HA
通讯作者：
VALKENBURG, HA
影响因子：
27.4
作者：
Bruyere, O;Richy, F;Reginster, JY
通讯作者：
Reginster, JY
影响因子：
2.6
作者：
Gulhan, Ibrahim;Bilgili, Sibel;Posaci, Cemal
通讯作者：
Posaci, Cemal
影响因子：
5.5
作者：
Botha-Scheepers, S;Watt, I;Kloppenburg, M
通讯作者：
Kloppenburg, M
影响因子：
27.4
作者：
Bruyere, O.;Delferriere, D.;Reginster, J-Y
通讯作者：
Reginster, J-Y