雷奈酸锶治疗男性骨质疏松症的疗效和安全性。

Efficacy and safety of strontium ranelate in the treatment of osteoporosis in men.

机构信息

Department of Endocrinology and Unit for Osteoporosis and Metabolic Bone Diseases, Ghent University Hospital, De Pintelaan 185, 9000 Ghent, Belgium.

出版信息

J Clin Endocrinol Metab. 2013 Feb;98(2):592-601. doi: 10.1210/jc.2012-3048. Epub 2013 Jan 22.

DOI:10.1210/jc.2012-3048

PMID:23341486

Abstract

CONTEXT: Strontium ranelate reduces vertebral and nonvertebral fracture risk in postmenopausal osteoporosis. OBJECTIVE: The objective of this study was to determine the efficacy and safety of strontium ranelate in osteoporosis in men over 2 years (main analysis after 1 year). DESIGN: This was an international, unbalanced (2:1), double-blind, randomized placebo-controlled trial (MALEO [MALE Osteoporosis]). SETTING: This international study included 54 centers in 14 countries. PARTICIPANTS: PARTICIPANTS were 261 white men with primary osteoporosis. INTERVENTION: Strontium ranelate at 2 g/d (n = 174) or placebo (n = 87) was administered. MAIN OUTCOME MEASURES: Lumbar spine (L2-L4), femoral neck, and total hip bone mineral density (BMD), biochemical bone markers, and safety were measured. RESULTS: Baseline characteristics were similar in both groups in the whole population (age, 72.9 ± 6.0 years; lumbar spine BMD T-score, -2.7 ± 1.0; femoral neck BMD T-score, -2.3 ± 0.7). Men who received strontium ranelate over 2 years had greater increases in lumbar spine BMD than those who received placebo (relative change from baseline to end, 9.7% ± 7.5% vs 2.0% ± 5.5%; between-group difference estimate (SE), 7.7% (0.9%); 95% confidence interval, 5.9%-9.5%; P < .001). There were also significant between-group differences in relative changes in femoral neck BMD (P < .001) and total hip BMD (P < .001). At the end of treatment, mean levels of serum cross-linked telopeptides of type I collagen, a marker of bone resorption, were increased in both the strontium ranelate group (10.7% ± 58.0%; P = .022) and the placebo group (34.9% ± 65.8%; P < .001). The corresponding mean changes of bone alkaline phosphatase, a marker of bone formation, were 6.4% ± 28.5% (P = .005) and 1.9% ± 25.4% (P = .505), respectively. After 2 years, the blood strontium level (129 ± 66 μmol/L) was similar to that in trials of postmenopausal osteoporosis. Strontium ranelate was generally well tolerated. CONCLUSIONS: The effects of strontium ranelate on BMD in osteoporotic men were similar to those in postmenopausal osteoporotic women, supporting its use in the treatment of osteoporosis in men.

摘要

背景：雷奈酸锶可降低绝经后骨质疏松症患者的椎体和非椎体骨折风险。

目的：本研究旨在确定雷奈酸锶在男性骨质疏松症患者中的疗效和安全性，随访时长为 2 年（主要分析在 1 年后进行）。

设计：这是一项国际性、不均衡（2:1）、双盲、随机安慰剂对照试验（MALEO [男性骨质疏松症]）。

地点：该国际研究在 14 个国家的 54 个中心进行。

参与者：261 名白人男性原发性骨质疏松症患者。

干预：雷奈酸锶 2 g/d（n = 174）或安慰剂（n = 87）。

主要观察指标：腰椎（L2-L4）、股骨颈和全髋骨密度（BMD）、生化骨标志物和安全性。

结果：在整个人群中，两组的基线特征相似（年龄，72.9 ± 6.0 岁；腰椎 BMD T 评分，-2.7 ± 1.0；股骨颈 BMD T 评分，-2.3 ± 0.7）。接受雷奈酸锶治疗 2 年的男性腰椎 BMD 增加幅度大于接受安慰剂治疗的男性（从基线到治疗结束时的相对变化，9.7% ± 7.5%比 2.0% ± 5.5%；组间差异估计值（SE），7.7%（0.9%）；95%置信区间，5.9%-9.5%；P <.001）。股骨颈 BMD（P <.001）和全髋 BMD（P <.001）的相对变化也存在显著的组间差异。治疗结束时，血清Ⅰ型胶原交联肽（一种骨吸收标志物）的平均水平在雷奈酸锶组（10.7% ± 58.0%；P =.022）和安慰剂组（34.9% ± 65.8%；P <.001）均升高。相应的骨碱性磷酸酶（一种骨形成标志物）的平均变化分别为 6.4% ± 28.5%（P =.005）和 1.9% ± 25.4%（P =.505）。2 年后，血锶水平（129 ± 66 μmol/L）与绝经后骨质疏松症试验中的水平相似。雷奈酸锶总体上耐受性良好。

结论：雷奈酸锶对男性骨质疏松症患者 BMD 的影响与绝经后骨质疏松症女性相似，支持其用于男性骨质疏松症的治疗。