The Antiresorptive Effects of a Single Dose of Zoledronate Persist for Two Years: A Randomized, Placebo-Controlled Trial in Osteopenic Postmenopausal Women
The Antiresorptive Effects of a Single Dose of Zoledronate Persist for Two Years: A Randomized, Placebo-Controlled Trial in Osteopenic Postmenopausal Women
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DOI：
10.1210/jc.2008-2241
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发表时间：
2009-02-01
影响因子：
5.8
通讯作者：
Reid, Ian R.
中科院分区：
文献类型：
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作者：
Grey, Andrew;Bolland, Mark J.;Reid, Ian R.
背景：每年静脉注射5 mg唑来膦酸盐可降低骨折风险。5毫克唑来膦酸盐的最佳给药间隔尚不清楚。目的：我们的目的是确定一个单一的5毫克剂量iv唑来膦酸盐的抗骨吸收作用的持续时间。设计，设置，和参与者：我们进行了一项双盲，随机，安慰剂对照试验，在一个学术研究中心，在50名绝经后骨质疏松妇女的志愿者样本中进行了2年以上。干预包括5毫克唑来膦酸盐。主要结果测量：腰椎、股骨近端和全身骨转换和骨密度的生化标志物。与安慰剂相比，唑来膦酸治疗使骨转换的四种标志物的平均水平降低至少38%（范围38-45%）（每种标记物P < 0.0001）。2年后，唑来膦酸盐组腰椎骨密度平均高于安慰剂组5.7%（95%置信区间= 4.0-7.4），股骨近端骨密度平均高于安慰剂组3.9%（2.2-5.7），全身骨密度平均高于安慰剂组1.7%（0.8-2.5）（每个骨骼部位P < 0.0001）。在12个月和24个月时，骨转换和骨密度标志物的组间差异相似。轻度继发性甲状旁腺功能亢进是目前在整个研究中zoledronate group.Conclusion：一个单一的5毫克剂量的zoledronate的抗骨吸收作用持续至少2年。在12个月和24个月时，对骨转换和骨矿物质密度标志物的影响程度相当。唑来膦酸盐给药间隔长达2年可能与抗骨折疗效相关;临床试验调查这种可能性是合理的。（临床内分泌代谢杂志94：538-544，2009）
Context: Annual iv administration of 5 mg zoledronate decreases fracture risk. The optimal dosing interval of 5 mg zoledronate is not known.Objective: Our objective was to determine the duration of antiresorptive action of a single 5-mg dose of iv zoledronate.Design, Setting, and Participants: We conducted a double-blind, randomized, placebo-controlled trial over 2 yr at an academic research center, in a volunteer sample of 50 postmenopausal women with osteopenia.Intervention: Intervention included 5 mg zoledronate.Main Outcome Measures: Biochemical markers of bone turnover and bone mineral density of the lumbar spine, proximal femur, and total body.Results: Compared with placebo, zoledronate treatment decreased mean levels of each of four markers of bone turnover by at least 38% (range 38-45%) for the duration of the study (P < 0.0001 for each marker). After 2 yr, bone mineral density was higher in the zoledronate group than the placebo group by an average of 5.7% (95% confidence interval = 4.0-7.4) at the lumbar spine, 3.9% (2.2-5.7) at the proximal femur, and 1.7% (0.8-2.5) at the total body (P < 0.0001 for each skeletal site). Between-groups differences in markers of bone turnover and bone mineral density were similar at 12 and 24 months. Mild secondary hyperparathyroidism was present throughout the study in the zoledronate group.Conclusion: The antiresorptive effects of a single 5-mg dose of zoledronate are sustained for at least 2 yr. The magnitudes of the effects on markers of bone turnover and bone mineral density are comparable at 12 and 24 months. Administration of zoledronate at intervals of up to 2 yr may be associated with antifracture efficacy; clinical trials to investigate this possibility are justified. (J Clin Endocrinol Metab 94: 538-544, 2009)