一项针对前列腺癌亚洲男性雄激素剥夺所致骨丢失的每月口服米诺膦酸或每半年皮下注射地舒单抗的随机、开放标签、对照试验：米诺膦酸和地舒单抗预防骨质疏松症（PROMADE）研究。
A randomized, open-label, controlled trial of monthly oral minodronate or semiannual subcutaneous injection of denosumab for bone loss by androgen deprivation in Asian men with prostate cancer: the PRevention of Osteopenia with Minodronate And DEnosumab (PROMADE) study.
机构信息
Department of Urology and Andrology, Kori Hospital, Kansai Medical University, 8-45 Kori Hondori cyo, Neyagawa, Osaka, 572-8551, Japan.
Department of Urology and Andrology, Kansai Medical University Hospital, Hirakata, 2-3-1 Shin-machi, Hirakata, Osaka, 573-1191, Japan.
出版信息
Osteoporos Int. 2020 Jul;31(7):1251-1259. doi: 10.1007/s00198-019-05271-5. Epub 2020 Jan 28.
UNLABELLED
There is still a lack of evidence that minodronate or denosumab prevents bone loss due to androgen deprivation therapy (ADT) in non-Western patients. This study showed that both drugs significantly improved lumbar spine and total hip bone mineral density in Asian men with prostate cancer who received ADT.
INTRODUCTION
To evaluate whether monthly oral minodronate or semiannual subcutaneous injection of denosumab improves bone mineral density (BMD) in Asian men with prostate cancer (PCa) receiving ADT.
METHODS
A multicenter, open-label, randomized, controlled study including patients with hormone-sensitive PCa without bone metastasis receiving ADT was performed. Patients were randomized (1:1:1) to minodronate, denosumab, or no agent control groups. The primary end point was the mean percentage change in BMD at the lumbar spine at 12 months. Secondary end points were the mean percentage change in BMD at the femoral neck and total hip and changes in bone turnover markers. Statistical comparison was performed using analysis of covariance.
RESULTS
Of the 147 subjects enrolled in this study, 102 were randomly assigned into the minodronate (n = 36), denosumab (n = 36), and control (n = 30) groups. The percentage change in BMD at the lumbar spine was significantly improved in the minodronate (2.5%, p < 0.05) and denosumab groups (4.0%, p < 0.01) compared with that in the control group (- 0.1%). Denosumab increased BMD at the femoral neck and total hip at 12 months, whereas minodronate only increased BMD at the total hip compared with controls (all p < 0.05). The percentage change in bone turnover markers at 12 months was significantly lower in the minodronate and denosumab groups compared with that in the control group (both p < 0.01).
CONCLUSION
Minodronate or denosumab can be used for preventing bone loss related to ADT in Asian patients with PCa.
未注明
目前仍缺乏证据表明米诺膦酸或地舒单抗可预防非西方患者因雄激素剥夺疗法（ADT）而导致的骨质流失。本研究表明，这两种药物均可显著改善接受 ADT 的亚洲男性前列腺癌患者的腰椎和全髋骨密度。
引言
评估每月口服米诺膦酸或每半年皮下注射地舒单抗是否可改善接受 ADT 的亚洲男性前列腺癌（PCa）患者的骨密度（BMD）。
方法
进行了一项多中心、开放性、随机、对照研究，纳入了无骨转移且正在接受 ADT 的激素敏感型 PCa 患者。患者按 1:1:1 的比例随机分为米诺膦酸组、地舒单抗组或无药物对照组。主要终点为 12 个月时腰椎 BMD 的平均百分比变化。次要终点为股骨颈和全髋关节 BMD 的平均百分比变化以及骨转换标志物的变化。采用协方差分析进行统计学比较。
结果
在这项研究中，共有 147 名受试者入组，其中 102 名被随机分为米诺膦酸组（n = 36）、地舒单抗组（n = 36）和对照组（n = 30）。与对照组（-0.1%）相比，米诺膦酸组（2.5%，p < 0.05）和地舒单抗组（4.0%，p < 0.01）的腰椎 BMD 百分比变化明显改善。地舒单抗组在 12 个月时还增加了股骨颈和全髋关节的 BMD，而米诺膦酸组仅增加了全髋关节的 BMD（均 p < 0.05）。与对照组相比，米诺膦酸组和地舒单抗组在 12 个月时的骨转换标志物百分比变化明显更低（均 p < 0.01）。
结论
米诺膦酸或地舒单抗可用于预防亚洲 PCa 患者接受 ADT 相关的骨质流失。
Zotero 插件