Ringe Johann D, Dorst Alfred, Farahmand Parvis
West German Osteoporosis Center (WOC) and Medical Clinic 4, Klinikum Leverkusen, University of Cologne, Germany.
Arzneimittelforschung. 2010;60(5):267-72. doi: 10.1055/s-0031-1296284.
In an open-label, prospective, controlled, 12-month study the effects of strontium ranelate (SR, CAS 135459-87-9) or alendronate (CAS 129318-43-0) on bone mineral density (BMD) were compared in 152 men with primary osteoporosis. Patients were randomized to SR 2 g/day (n = 76) or alendronate 70 mg/week (n = 76) supplemented daily with 1200 mg calcium and 800 IU vitamin D. The main outcome measure was percent change in lumbar spine and total hip BMD from baseline. Mean BMD (+/- SD) increased by 5.8 +/- 3.7% at the lumbar spine and 3.5 +/- 2.8% at the total hip with SR compared to increases of 4.5 +/- 3.4 % and 2.7 +/- 3.2%, respectively, with alendronate. Increases in BMD in the SR group are consistent with 1-year results from two pivotal fracture studies in postmenopausal women with osteoporosis. SR was associated with a 22% greater increase in BMD at the lumbar spine (p = 0.033) and 23% greater increase at the total hip (p = 0.002) than alendronate. New fractures were observed in 7 SR and 10 alendronate patients. Height loss (-0.1 +/- 0.7 cm) was less with SR compared with alendronate (-0.5 +/- 0.8 cm) (p = 0.026). SR was also associated with significantly greater reductions in back pain and analgesic use scores. Adverse events were experienced by 28 (37%) patients in the SR group and 38 (50%) patients in the alendronate group, none of which were serious. In men with osteoporosis, SR produced significantly greater mean increases in BMD over 12 months compared with alendronate, an agent already approved for male osteoporosis. Mean increases in BMD with SR in men were similar to those previously documented for this agent in postmenopausal women, suggesting that similar benefits on anti-fracture efficacy may be expected.
在一项开放标签、前瞻性、对照、为期12个月的研究中，对152名原发性骨质疏松症男性患者比较了雷奈酸锶（SR，化学物质登记号135459-87-9）或阿仑膦酸钠（化学物质登记号129318-43-0）对骨密度（BMD）的影响。患者被随机分为每日服用2g SR组（n = 76）或每周服用70mg阿仑膦酸钠组（n = 76），并每日补充1200mg钙和800IU维生素D。主要观察指标是腰椎和全髋部骨密度相对于基线的变化百分比。与阿仑膦酸钠组相比，SR组腰椎骨密度平均增加了5.8±3.7%，全髋部增加了3.5±2.8%，而阿仑膦酸钠组腰椎和全髋部骨密度分别增加了4.5±3. %和2.7±3.2%。SR组骨密度的增加与两项针对绝经后骨质疏松症女性的关键骨折研究的1年结果一致。与阿仑膦酸钠相比，SR使腰椎骨密度增加幅度高22%（p = 0.033），全髋部高23%（p = 0.002）。在服用SR的7名患者和服用阿仑膦酸钠的10名患者中观察到新发骨折。与阿仑膦酸钠组（-0.5±0.8cm）相比，SR组身高降低较少（-0.1±0.7cm）（p = 0.026）。SR还与背痛和止痛药物使用评分的显著更大幅度降低相关。SR组28名（37%）患者和阿仑膦酸钠组38名（50%）患者出现不良事件，但均不严重。在患有骨质疏松症的男性中，与已被批准用于男性骨质疏松症的阿仑膦酸钠相比，SR在12个月内使骨密度平均增加幅度显著更大。男性服用SR时骨密度的平均增加幅度与之前在绝经后女性中记录的该药物的增加幅度相似，这表明在抗骨折疗效方面可能会有类似的益处。
