Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab
Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab
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DOI：
10.1007/s00198-019-05146-9
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发表时间：
2019-10-18
影响因子：
4
通讯作者：
Grauer, A.
中科院分区：
文献类型：
--
作者：
Kendler, D. L.;Bone, H. G.;Grauer, A.
Romosozumab是一种刺激骨形成和减少骨吸收的疗法。在这项低BMD绝经后女性的研究中，停药或接受地舒单抗治疗一段时间后，第二个疗程的romosozumab分别增加或维持BMD，并且耐受性良好，提供了对治疗序列选择的深入了解。在骨折风险高的患者中，刺激骨形成的治疗可快速增加BMD;目前可用的药物甲状旁腺激素受体激动剂仅限于2年的终生暴露，通常用于单疗程。然而，对于长期骨质疏松症管理，第二个疗程可能是合适的。Romosozumab是一种具有增加骨形成和减少骨吸收双重作用的疗法，可在12个月内降低骨折风险。在这里，我们报告了第二个romosozumab疗程的疗效和安全性。在这项2期剂量探索研究中，低骨量（T评分=-3.5）的绝经后妇女接受romosozumab或安慰剂（0-24个月），然后接受安慰剂或denosumab（24-36个月）;参与者然后接受一年的romosozumab（36-48个月）。在进入36-48个月期间的167名参与者中，35名最初被随机分配到每月210 mg的romosozumab。在接受romosozumab 210 mg每月一次，随后接受安慰剂的参与者中，第二个romosozumab疗程（n = 19）增加腰椎（分别为12.4%; 12.0%）和全髋关节（分别为6.0%; 5.5%）BMD的数量与初始治疗（0-12个月）相似。地舒单抗治疗后，第二个romosozumab疗程（n = 16）增加了腰椎BMD（2.3%），并维持了全髋BMD。第一个和第二个romosozumab疗程的安全性特征相似。结论：停药12个月后，第二个romosozumab疗程再次导致快速和大的BMD增加。地舒单抗治疗后，romosozumab治疗的BMD增量小于初始治疗。在第二个疗程期间未观察到新的安全性结果。
Romosozumab is a therapy that stimulates bone formation and reduces bone resorption. In this study of postmenopausal women with low BMD, a second course of romosozumab following a period off treatment or on denosumab increased or maintained BMD, respectively, and was well tolerated, providing insight into treatment sequence options. Introduction In patients with high fracture risk, therapies that stimulate bone formation provide rapid BMD gains; currently available agents, parathyroid hormone receptor agonists, are limited to a 2-year lifetime exposure and generally used for a single treatment course. However, for long-term osteoporosis management, a second treatment course may be appropriate. Romosozumab, a therapy with the dual effect of increasing bone formation and decreasing bone resorption, reduces fracture risk within 12 months. Here, we report efficacy and safety of a second romosozumab course. Methods In this phase 2, dose-finding study, postmenopausal women with low bone mass (T-score = - 3.5) received romosozumab or placebo (month 0-24) followed by placebo or denosumab (month 24-36); participants then received a year of romosozumab (month 36-48). Results Of 167 participants who entered the month 36-48 period, 35 had been initially randomized to romosozumab 210 mg monthly. In participants who received romosozumab 210 mg monthly followed by placebo, a second romosozumab course (n = 19) increased BMD by amounts similar to their initial treatment (month 0-12) at the lumbar spine (12.4%; 12.0%, respectively) and total hip (6.0%; 5.5%, respectively). Following denosumab, a second romosozumab course (n = 16) increased BMD at the lumbar spine (2.3%) and maintained BMD at the total hip. Safety profiles were similar between first and second romosozumab courses. Conclusions After 12 months off-treatment, a second romosozumab course again led to rapid and large BMD gains. Following denosumab, BMD gains with romosozumab were smaller than with initial treatment. No new safety findings were observed during the second course.