在停止使用丹诺苏马布后进行佐莱德龙酸序列治疗以防止骨矿物质密度降低:一项随机临床试验
Chia-Che Lee1,2, Chen-Yu Wang3,4, Hung-Kuan Yen1
1Department of Orthopedic Surgery, National Taiwan University Hospital, Taipei, Taiwan.
JAMA network open
|November 11, 2024
概括
在停止服用德诺苏马布后,连续的佐勒德罗纳特疗法在第一年内显示腰椎骨质损失. 在切换之前长时间使用denosumab可能会加剧骨密度下降,这表明需要进一步研究.
科学领域:
- 骨代谢和骨质疏松症研究研究
- 对骨健康的药理干预措施
背景情况:
- 停止使用登苏马布可以导致快速的骨质损失和骨折风险增加.
- 之前对莱德酸盐作为后代诺苏马布序列治疗的疗效的研究已经产生了不一致的结果.
研究的目的:
- 为了评估序列性列酸盐治疗在停止使用登苏马布后预防骨矿物质密度 (BMD) 损失的有效性.
- 为了评估在停止使用登苏马布和过渡到佐莱德酸盐后的第一年内骨质量变化.
主要方法:
- 一个前性的,开放的,随机的临床试验 (Denosumab 序列疗法) 涉及101名患者 (绝经后的女性和50岁以上的男性),先前接受过denosumab 治疗.
- 参与者被随机分配,在第一年 (ZOL组) 继续服用德诺苏马布 (A组) 或接受一剂索莱德罗纳特 (5毫克).
- 首要结局包括腰椎 (LS-BMD),整个部 (TH-BMD) 和大腿部 (FN-BMD) 的百分比变化.
主要成果:
- 与A组 (1.30%) 相比,ZOL组在第一年 (P=.03) 显示LS-BMD的中位数显著下降 (-0.68%),而A组 (1.30%) 的中位数显著下降.
- 两组之间没有观察到TH-BMD或FN-BMD的显著差异.
- 与A组 (P=.003) 相比,接受佐莱德罗纳酸和先前3年以上的登苏马布治疗的患者经历了较大的LS-BMD下降 (-3.20%).
结论:
- 在停止服用德诺苏马布后,连续的佐勒德罗纳特治疗与第一年腰椎骨损失有关.
- 较长的先前denosumab治疗持续时间与在zoledronate治疗后进一步的LS-BMD下降相关.
- 需要进一步的研究,包括大规模的随机试验,以优化长期使用denosumab后的顺序治疗策略.
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