Romosozumab versus denosumab in long-term users of glucocorticoids: A pilot randomized controlled trial

IF 9 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Journal of Internal Medicine Pub Date : 2024-10-10 DOI:10.1111/joim.20017
Chi Chiu Mok, Kar Li Chan, Sau Mei Tse, Sammy Pak Lam Chen, Kathryn Choon Beng Tan, Wai Han Ma
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Abstract

Objective

To compare the efficacy of romosozumab (ROMO) and denosumab (DEN) in prevalent long-term glucocorticoid (GC) users.

Methods

Adult patients receiving oral prednisolone (≥5 mg/day) with high risk of fracture were randomized to receive subcutaneous ROMO (210 mg monthly) or DEN (60 mg 6-monthly) for 12 months, followed by DEN for two more doses. The primary end point was the change in spine bone mineral density (BMD) from Months 0 to 12. Secondary end points included changes in BMD of the spine/hip/femoral neck and bone turnover markers at various time points and adverse events.

Results

Seventy patients (age 62.6 ± 9.1 years; 96% women; median prednisolone dose 5.0 mg/day; duration of therapy 10.7 ± 7.4 years) were enrolled, and 63 completed the study. At Month 12, the spine BMD increased significantly in both ROMO (+7.3% ± 4.5%; p < 0.001) and DEN (+2.3% ± 3.1%; p < 0.001) groups. The absolute spine BMD gain from Months 0 to 12 was significantly greater in ROMO-treated patients (p < 0.001). Although the total hip BMD at Month 12 also increased significantly in the ROMO (+1.6% ± 3.3%; p = 0.01) and DEN groups (+1.6% ± 2.6%; p = 0.003), the absolute BMD gain was not significantly different between the groups. At Month 24, the spine BMD continued to increase in both the ROMO (+9.7% ± 4.8%; p < 0.001) and DEN group (+3.0% ± 3.0%; p < 0.001) compared to baseline, and the absolute BMD gain remained significantly greater in ROMO-treated patients. The total hip BMD continued to increase in both groups (ROMO +2.9% ± 3.7%; p < 0.001; DEN +2.2% ± 3.4%; p = 0.001), but the changes from baseline were similar. Injection site reaction was more frequently reported in ROMO-treated patients.

Conclusion

ROMO was superior to DEN in raising the spine BMD at Month 12 in chronic GC users. After switching to DEN, ROMO-treated patients continued to gain spine BMD to a greater extent than DEN until Month 24.

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在长期使用糖皮质激素的患者中,Romosozumab 与 Denosumab 孰优孰劣?随机对照试验
目的比较romosozumab(ROMO)和denosumab(DEN)对糖皮质激素(GC)长期使用者的疗效:方法:对口服泼尼松龙(≥5毫克/天)且有骨折高风险的成年患者进行随机分组,接受皮下注射ROMO(210毫克/月)或DEN(60毫克/6个月)治疗12个月,然后再接受两次DEN治疗。主要终点是脊柱骨质密度 (BMD) 从第 0 个月到第 12 个月的变化。次要终点包括不同时间点脊柱/髋部/股骨颈骨密度和骨转换标志物的变化以及不良事件:70名患者(年龄为62.6 ± 9.1岁;96%为女性;中位泼尼松龙剂量为5.0毫克/天;疗程为10.7 ± 7.4年)参加了研究,其中63人完成了研究。在第 12 个月,ROMO 和 DEN 的脊柱 BMD 均显著增加(+7.3% ± 4.5%;P 结论:ROMO 和 DEN 在提高脊柱 BMD 方面更优:在第 12 个月,ROMO 在提高慢性 GC 使用者的脊柱 BMD 方面优于 DEN。在改用 DEN 后,ROMO 治疗的患者直到第 24 个月的脊柱 BMD 增幅仍高于 DEN。
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来源期刊
Journal of Internal Medicine
Journal of Internal Medicine 医学-医学:内科
CiteScore
22.00
自引率
0.90%
发文量
176
审稿时长
4-8 weeks
期刊介绍: JIM – The Journal of Internal Medicine, in continuous publication since 1863, is an international, peer-reviewed scientific journal. It publishes original work in clinical science, spanning from bench to bedside, encompassing a wide range of internal medicine and its subspecialties. JIM showcases original articles, reviews, brief reports, and research letters in the field of internal medicine.
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