New Mexico Clinical Research & Osteoporosis Center, 300 Oak St NE, Albuquerque, NM 87106, United States.
Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.
J Bone Miner Res. 2024 May 2;39(4):473-483. doi: 10.1093/jbmr/zjae028.
Romosozumab treatment in women with postmenopausal osteoporosis increases bone formation while decreasing bone resorption, resulting in large BMD gains to reduce fracture risk within 1 yr. DXA-based 3D modeling of the hip was used to assess estimated changes in cortical and trabecular bone parameters and map the distribution of 3D changes in bone parameters over time in patients from 2 randomized controlled clinical trials: FRAME (romosozumab vs placebo followed by denosumab) and ARCH (romosozumab vs alendronate followed by alendronate). For each study, data from a subset of ~200 women per treatment group who had TH DXA scans at baseline and months 12 and 24 and had provided consent for future research were analyzed post hoc. 3D-SHAPER software v2.11 (3D-SHAPER Medical) was used to generate patient-specific 3D models from TH DXA scans. Percentage changes from baseline to months 12 and 24 in areal BMD (aBMD), integral volumetric BMD (vBMD), cortical thickness, cortical vBMD, cortical surface BMD (sBMD), and trabecular vBMD were evaluated. Data from 377 women from FRAME (placebo, 190; romosozumab, 187) and 368 women from ARCH (alendronate, 185; romosozumab, 183) with evaluable 3D assessments at baseline and months 12 and 24 were analyzed. At month 12, treatment with romosozumab vs placebo in FRAME and romosozumab vs alendronate in ARCH resulted in greater increases in aBMD, integral vBMD, cortical thickness, cortical vBMD, cortical sBMD, and trabecular vBMD (P < .05 for all). At month 24, cumulative gains in all parameters were greater in the romosozumab-to-denosumab vs placebo-to-denosumab sequence and romosozumab-to-alendronate vs alendronate-to-alendronate sequence (P < .05 for all). 3D-SHAPER analysis provides a novel technique for estimating changes in cortical and trabecular parameters from standard hip DXA images. These data add to the accumulating evidence that romosozumab improves hip bone density and structure, thereby contributing to the antifracture efficacy of the drug.
罗莫佐单抗治疗绝经后骨质疏松症女性可增加骨形成，减少骨吸收，从而在 1 年内大幅增加骨密度，降低骨折风险。使用基于 DXA 的髋关节 3D 建模来评估 2 项随机对照临床试验（FRAME[罗莫佐单抗与安慰剂，随后为地舒单抗]和 ARCH[罗莫佐单抗与阿仑膦酸钠，随后为阿仑膦酸钠]）中患者的皮质骨和小梁骨参数的估计变化，并绘制随时间推移骨参数 3D 变化的分布情况。每个研究中，对大约 200 名接受治疗的女性中的每一组（每组约 200 名女性）进行了基线和第 12 个月和第 24 个月的 TH DXA 扫描，并同意进行进一步的研究，然后对这些数据进行了事后分析。使用 3D-SHAPER 软件 v2.11（3D-SHAPER Medical）根据 TH DXA 扫描生成患者特定的 3D 模型。评估了从基线到第 12 个月和第 24 个月的面积骨密度（aBMD）、积分容积骨密度（vBMD）、皮质厚度、皮质 vBMD、皮质表面骨密度（sBMD）和小梁 vBMD 的百分比变化。对 FRAME（安慰剂，190 例；罗莫佐单抗，187 例）和 ARCH（阿仑膦酸钠，185 例；罗莫佐单抗，183 例）中 377 名和 368 名女性在基线和第 12 个月和第 24 个月时具有可评估的 3D 评估的数据进行了分析。在 FRAME 中，与安慰剂相比，罗莫佐单抗治疗在第 12 个月时导致 aBMD、积分 vBMD、皮质厚度、皮质 vBMD、皮质 sBMD 和小梁 vBMD 增加（所有 P<0.05）；在 ARCH 中，与阿仑膦酸钠相比，罗莫佐单抗治疗在第 12 个月时导致 aBMD、积分 vBMD、皮质厚度、皮质 vBMD、皮质 sBMD 和小梁 vBMD 增加（所有 P<0.05）。在第 24 个月时，在罗莫佐单抗-地舒单抗与安慰剂-地舒单抗序贯治疗和罗莫佐单抗-阿仑膦酸钠与阿仑膦酸钠-阿仑膦酸钠序贯治疗中，所有参数的累积增益均较大（所有 P<0.05）。3D-SHAPER 分析为从标准髋关节 DXA 图像估计皮质和小梁参数变化提供了一种新的技术。这些数据增加了越来越多的证据表明，罗莫佐单抗可改善髋骨密度和结构，从而有助于该药物的抗骨折疗效。
