唑来膦酸单次给药可在使用罗莫佐单抗第二疗程后长达 2 年内保持骨密度。
A single dose of zoledronate preserves bone mineral density for up to 2 years after a second course of romosozumab.
机构信息
Oregon Osteoporosis Center, 2881 NW Cumberland Road, Portland, OR 97210, USA.
Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.
出版信息
Osteoporos Int. 2020 Nov;31(11):2231-2241. doi: 10.1007/s00198-020-05502-0. Epub 2020 Jul 4.
UNLABELLED
This phase 2 study evaluated the efficacy and safety of transitioning to zoledronate following romosozumab treatment in postmenopausal women with low bone mass. A single dose of 5 mg zoledronate generally maintained the robust BMD gains accrued with romosozumab treatment and was well tolerated.
INTRODUCTION
Follow-on therapy with an antiresorptive agent is necessary to maintain the skeletal benefits of romosozumab therapy. We evaluated the use of zoledronate following romosozumab treatment.
METHODS
This phase 2, dose-finding study enrolled postmenopausal women with low bone mineral density (BMD). Subjects who received various romosozumab doses or placebo from months 0-24 were rerandomized to denosumab (60 mg SC Q6M) or placebo for 12 months, followed by open-label romosozumab (210 mg QM) for 12 months. At month 48, subjects who had received active treatment for 48 months were assigned to no further active treatment and all other subjects were assigned to zoledronate 5 mg IV. Efficacy (BMD, P1NP, and β-CTX) and safety were evaluated for 24 months, up to month 72.
RESULTS
A total of 141 subjects entered the month 48-72 period, with 51 in the no further active treatment group and 90 in the zoledronate group. In subjects receiving no further active treatment, lumbar spine (LS) BMD decreased by 10.8% from months 48-72 but remained 4.2% above the original baseline. In subjects receiving zoledronate, LS BMD was maintained (percentage changes: - 0.8% from months 48-72; 12.8% from months 0-72). Similar patterns were observed for proximal femur BMD in both groups. With no further active treatment, P1NP and β-CTX decreased but remained above baseline at month 72. Following zoledronate, P1NP and β-CTX levels initially decreased but approached baseline by month 72. No new safety signals were observed.
CONCLUSION
A zoledronate follow-on regimen can maintain robust BMD gains achieved with romosozumab treatment.
目的
本研究旨在评估绝经后低骨量女性使用唑来膦酸治疗罗莫佐单抗治疗后的疗效和安全性。单次使用 5mg 唑来膦酸通常可以维持罗莫佐单抗治疗带来的骨密度（BMD）显著增加，并具有良好的耐受性。
简介
需要使用抗吸收剂进行后续治疗以维持罗莫佐单抗治疗的骨骼获益。我们评估了罗莫佐单抗治疗后使用唑来膦酸的情况。
方法
这是一项 2 期、剂量探索研究，纳入了绝经后低骨密度（BMD）的女性患者。接受了不同剂量罗莫佐单抗或安慰剂治疗 0-24 个月的患者，再随机分配接受地舒单抗（60mg SC Q6M）或安慰剂治疗 12 个月，随后接受为期 12 个月的开放标签罗莫佐单抗（210mg QM）治疗。在第 48 个月时，接受了 48 个月的治疗的患者被分配为不再进行任何积极治疗，其余所有患者被分配为静脉注射唑来膦酸 5mg。在第 72 个月时，评估了 24 个月的疗效（BMD、P1NP 和 β-CTX）和安全性。
结果
共有 141 名患者进入第 48-72 个月的研究，其中 51 名患者未进行任何进一步的积极治疗，90 名患者接受唑来膦酸治疗。在未进行任何进一步的积极治疗的患者中，第 48-72 个月时腰椎（LS）BMD 下降了 10.8%，但仍比原始基线高出 4.2%。在接受唑来膦酸治疗的患者中，LS BMD 保持不变（第 48-72 个月的百分比变化：-0.8%；第 0-72 个月的百分比变化：12.8%）。两组的股骨近端 BMD 也出现了类似的模式。在未进行任何进一步的积极治疗的患者中，P1NP 和 β-CTX 下降，但在第 72 个月时仍高于基线。接受唑来膦酸治疗后，P1NP 和 β-CTX 水平最初下降，但在第 72 个月时接近基线。未观察到新的安全性信号。
结论
唑来膦酸的后续治疗方案可以维持罗莫佐单抗治疗带来的骨密度显著增加。
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