Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial
Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial
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RISedronate 治疗糖皮质激素诱导的骨质疏松症合并类风湿性关节炎的疗效和安全性（RISOTTO 研究）：一项多中心、双盲、随机、安慰剂对照试验
DOI：
10.1080/14397595.2020.1812835
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发表时间：
2020
影响因子：
2.2
通讯作者：
Kurita Ta
中科院分区：
文献类型：
--
作者：
Fujieda Yuichiro;Horita Tetsuya;Nishimoto Naoki;Tanimura Kazuhide;Amasaki Yoshiharu;Kasahara Hideki;Furukawa Shin;Takeda Tsuyoshi;Fukaya Shinji;Matsui Kazuo;Tsutsumi Akito;Furusaki Akira;Sagawa Akira;Katayama Kou;Takeuchi Kaoru;Katsumata Kazuaki;Kurita Ta
目的尚无证据表明利塞膦酸钠（Risedronate）对类风湿性关节炎（RA）患者糖皮质激素诱导的骨质疏松症（GIO）有效。本研究的目的是探讨利塞膦酸钠对GIO并发RA的有效性和安全性。MethodsThis是一个为期6个月的随机，双盲，安慰剂对照试验的95例GIO并发RA从19个中心。主要终点是腰椎骨密度（L-BMD）较基线的变化。次要终点包括股骨颈和全髋BMD和骨转换标志物的变化，以及类风湿关节炎疾病活动评分（28个关节计数）。非创伤性脊柱骨折和不良事件的发生被跟踪作为safety endpoints. ResultsL-BMD的增加在利塞膦酸钠组显著大于安慰剂组（利塞膦酸钠：3.49% [95%CI：1.92-5.05] vs安慰剂：0.12% [95%CI：-2.07至2.30]，p<0.0001）。股骨颈和全髋骨密度无显著差异。尽管在28例患者中观察到不良事件，但均不被视为严重事件。非创伤性椎体骨折被确定在10 patients. ConclusionResedronate是有效的，增加L-BMD和耐受性良好的GIO并发RA患者。
ObjectiveNo evidence has shown the efficacy of Sodium Risedronate (Risedronate) for glucocorticoid-induced osteoporosis (GIO) in patients with Rheumatoid arthritis (RA). The aim of this study was to explore the effectiveness and safety of Risedronate for GIO complicated with RA.MethodsThis was a six-month randomized, double-blind, placebo-controlled trial of 95 patients with GIO complicated with RA from 19 centers. The primary endpoint was the change from baseline in lumbar spine bone mineral density (L-BMD). Secondary endpoints included changes in femoral neck and total hip BMD and bone turnover markers, as well as rheumatoid arthritis Disease Activity Score with 28-joint counts. Incident of non-traumatic spine fractures and adverse events were tracked as safety endpoints.ResultsIncrease in L-BMD was significantly greater in the Risedronate group compared to the Placebo group (Risedronate: 3.49% [95% CI: 1.92–5.05] vs Placebo: 0.12% [95% CI: −2.07 to 2.30],p< .0001). No significant difference was found in the femoral neck and total hip BMD. Although adverse events were observed in 28 patients, none were considered serious. Non-traumatic vertebral fractures were identified in 10 patients.ConclusionRisedronate was effective in increasing L-BMD and was well tolerated in patients with GIO complicated with RA.
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影响因子：
4
作者：
van den Hoek J;Boshuizen HC;Roorda LD;Tijhuis GJ;Nurmohamed MT;van den Bos GA;Dekker J
通讯作者：
Dekker J
每日利塞膦酸钠治疗男性和女性皮质类固醇引起的骨质疏松症的功效和安全性：一项随机试验。
影响因子：
6.2
作者：
D. Reid;R. Hughes;R. Laan;N. Sacco;D. Wenderoth;S. Adami;R. Eusebio;J. Devogelaer
通讯作者：
J. Devogelaer
类风湿性关节炎患者的骨折风险
影响因子：
1.6
作者：
Ao Xue;Su;Lei Jiang;Aimei Feng;Haifeng Guo;Pu Zhao
通讯作者：
Pu Zhao
DOI：
10.1111/j.1756-185x.2012.01729.x
发表时间：
2012-06-01
影响因子：
2.5
作者：
Lee, Seung-Geun;Park, Young-Eun;Baek, Seung-Hoon
通讯作者：
Baek, Seung-Hoon
影响因子：
158.5
作者：
Weinstein, Robert S.
通讯作者：
Weinstein, Robert S.