Effects of Denosumab Treatment and Discontinuation on Bone Mineral Density and Bone Turnover Markers in Postmenopausal Women with Low Bone Mass
Effects of Denosumab Treatment and Discontinuation on Bone Mineral Density and Bone Turnover Markers in Postmenopausal Women with Low Bone Mass
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DOI：
10.1210/jc.2010-1502
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发表时间：
2011-04-01
影响因子：
5.8
通讯作者：
Gallagher, J. Christopher
中科院分区：
文献类型：
--
作者：
Bone, Henry G.;Bolognese, Michael A.;Gallagher, J. Christopher
内容：地舒单抗治疗24个月可增加绝经后妇女的骨密度（BMD）并降低骨转换标志物（BTM）。目的：目的是确定在治疗中止后24个月内，预先注射地舒单抗或安慰剂对BMD、BTM和安全性的影响。设计：我们进行了一项3期、随机、双盲、平行组研究的停药扩展。参与者：共有256名平均年龄为59岁、平均腰椎T评分为-1.61的绝经后妇女参加了这项研究。干预措施：参与者每6个月接受安慰剂或60 mg地舒单抗，持续24个月，随后停止治疗24个月。主要结果测量：我们测量了BMD和BTM的百分比变化，并评估了安全性。在治疗后阶段入组的256名参与者中，87%完成了研究。与安慰剂相比，地舒单抗治疗24个月期间，BMD增加（腰椎，6.4%;全髋关节，3.6%; 1/3桡骨，1.4%），BTM降低（血清1型胶原C末端肽，63%; 1型前胶原N末端前肽，47%）。停药后，BMD下降，但先前接受地舒单抗治疗的组在这些部位的BMD仍高于先前接受安慰剂治疗的组（P
Context: Denosumab treatment for 24 months increased bone mineral density (BMD) and reduced bone turnover markers (BTM) in postmenopausal women.Objective: The aim was to determine the effects of prior denosumab or placebo injections on BMD, BTM, and safety over 24 months after treatment discontinuation.Design: We conducted an off-treatment extension of a phase 3, randomized, double-blind, parallel-group study.Participants: A total of 256 postmenopausal women with a mean age of 59 yr and a mean lumbar spine T-score of -1.61 at randomization participated in the study.Interventions: Participants received placebo or 60 mg denosumab every 6 months for 24 months, followed by 24 months off treatment.Main Outcome Measures: We measured the percentage changes in BMD and BTM, and evaluated safety.Results: Of the 256 participants enrolled in the posttreatment phase, 87% completed the study. During 24 months of denosumab treatment, BMD increased (lumbar spine, 6.4%; total hip, 3.6%; 1/3 radius, 1.4%), and BTM decreased (serum C-terminal telopeptide of type 1 collagen, 63%; and N-terminal propeptide of type 1 procollagen, 47%), compared with placebo. After discontinuation, BMD declined, but the previously treated denosumab group maintained higher BMD than the previously treated placebo group at these sites (P