Abstract: Strontium ranelate is a new orally administered agent for the treatment of women with postmenopausal osteoporosis that reduces the risk of vertebral and hip fractures. Evidence for the safety and efficacy of strontium ranelate comes from two large multinational trials, the SOTI (Spinal Osteoporosis Therapeutic Intervention) and TROPOS (Treatment Of Postmenopausal Osteoporosis) studies. The SOTI study evaluated vertebral fracture prevention in 1649 postmenopausal women with a mean age of 69 y. The subjects all had at least one previous vertebral fracture and a low spine bone mineral density (BMD) (equivalent to a Hologic spine T-score below –1.9). The strontium ranelate group had a 41% lower risk of a new vertebral fracture than the placebo group over the three-year study period (relative risk [RR]=0.59; 95% confidence interval [CI]: 0.48–0.73; p<0.001). The TROPOS study evaluated non-vertebral fracture prevention in 5091 postmenopausal women with a mean age of 77 y. The subjects were aged 74 y and over (or 70–74 y with one additional risk factor) and a low femoral neck BMD (equivalent to an NHANES III [Third National Health and Nutrition Examination Survey] T-score below –2.2). Over the three-year study period there was a 16% reduction in all non-vertebral fractures (RR=0.84; 95% CI 0.702–0.995; p=0.04) and a 19% reduction at the principal sites for non-vertebral fractures. The TROPOS study was not powered to investigate hip fracture risk. However, in a high risk group of women aged 74 y and over and with an NHANES III femoral neck T-score less than –2.4 there was a 36% reduction in hip fracture risk (RR=0.64; 95% CI: 0.412–0.997; p=0.046). The overall incidence of adverse events did not differ significantly from placebo and were generally mild and transient, the most common being nausea and diarrhea. Strontium ranelate is a useful addition to the range of anti-fracture treatments available for treating postmenopausal women with osteoporosis and is the only treatment proven to be effective at preventing both vertebral and hip fractures in women aged 80 y and over.
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机译：摘要：雷奈酸锶是一种口服的新型药物，用于治疗绝经后骨质疏松症的妇女，可降低椎骨和髋部骨折的风险。雷奈酸锶的安全性和有效性的证据来自两项大型的跨国试验，即SOTI（脊髓性骨质疏松症治疗干预）和TROPOS（绝经后骨质疏松症的治疗）研究。 SOTI研究评估了1649名平均年龄为69岁的绝经后妇女的椎骨骨折预防。所有受试者均具有至少一个先前的椎骨骨折和低的脊柱骨矿物质密度（BMD）（相当于Hologic脊柱T分数低于–1.9）。在三年的研究期内，雷奈酸锶组的新椎骨骨折风险比安慰剂组低41％（相对风险[RR] = 0.59; 95％置信区间[CI]：0.48-0.73; p <0.001 ）。 TROPOS研究评估了5091名平均年龄为77岁的绝经后妇女的非椎骨骨折预防效果。受试者年龄在74岁及以上（或70-74岁，并伴有另一种危险因素），股骨颈骨密度低（相当于NHANES III [第三次全国健康与营养检查调查] T评分低于–2.2）。在三年的研究期内，所有非椎骨骨折的患病率均降低了16％（RR = 0.84; 95％CI 0.702-0.995; p = 0.04），非椎骨骨折的主要部位降低了19％。 TROPOS研究无权调查髋部骨折的风险。但是，在74岁及以上且NHANES III股骨颈T分数小于–2.4的高危人群中，髋部骨折风险降低了36％（RR = 0.64; 95％CI：0.412–0.997） ; p = 0.046）。不良事件的总发生率与安慰剂没有显着差异，一般为轻度和短暂性，最常见的是恶心和腹泻。雷奈酸锶是可用于治疗绝经后骨质疏松妇女的一系列抗骨折治疗方法的有用补充，并且是经证实可有效预防80岁及以上女性的椎骨和髋部骨折的唯一疗法。
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