Division of Endocrinology and Metabolism, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University, Kaohsiung, Taiwan, ROC.
J Bone Miner Metab. 2010 May;28(3):328-33. doi: 10.1007/s00774-009-0136-9. Epub 2009 Dec 15.
The aim of this study was to evaluate the efficacy, safety, and tolerability of weekly alendronate administration on male osteoporosis in Taiwan. This 6-month, randomized, open-label controlled trial enrolled 46 men with osteoporosis who were randomized to either 70 mg alendronate once weekly (n = 23) or control (n = 23). Bone mineral density (BMD) of lumbar spine and hip and biochemical bone turnover markers were measured; adverse events and tolerability were assessed. Subjects treated with alendronate showed a significant increase in BMD of 5.5% (vs. 2% in control group) at the lumbar spine and 2.7% (vs. 0.7%) at the femoral neck (P < 0.05) at 6 months, respectively. There were also significant decreases in serum level of bone formation marker (bone-specific alkaline phosphatase) and urinary excretion of bone resorption marker (deoxypyridinoline) at 3 and 6 months. Thus, alendronate showed anti-osteoporotic effects by increasing BMD and decreasing the concentrations of bone markers. The adverse events were mild and showed no significant difference between the two groups on safety assessments.
本研究旨在评估每周给予阿伦膦酸钠在治疗台湾男性骨质疏松症的疗效、安全性和耐受性。这是一项为期 6 个月的随机、开放标签对照临床试验，共纳入 46 例骨质疏松症男性患者，随机分为每周 70mg 阿伦膦酸钠组（n=23）或对照组（n=23）。测量腰椎和髋部骨密度（BMD）和生化骨转换标志物；评估不良事件和耐受性。阿伦膦酸钠治疗组腰椎 BMD 显著增加 5.5%（对照组为 2%），股骨颈 BMD 显著增加 2.7%（对照组为 0.7%），分别在 6 个月时（P<0.05）。骨形成标志物（骨碱性磷酸酶）血清水平和骨吸收标志物（脱氧吡啶啉）尿排泄在 3 个月和 6 个月时也显著降低。因此，阿伦膦酸钠通过增加 BMD 和降低骨标志物浓度显示出抗骨质疏松作用。不良事件轻微，两组安全性评估无显著差异。
