The effects of abaloparatide on hip geometry and biomechanical properties in Japanese osteoporotic patients assessed using DXA-based hip structural analysis: results of the Japanese phase 3 ACTIVE-J trial

IF 3.1 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM
Teruki Sone, Kazuhiro Ohnaru, Takumi Sugai, Akiko Yamashita, Nobukazu Okimoto, Tetsuo Inoue, Toshio Matsumoto
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引用次数: 0

Abstract

Summary

Daily subcutaneous injection of 80 μg abaloparatide increased bone mineral density in Japanese patients with osteoporosis at high fracture risk in the ACTIVE-J trial. Dual-energy X-ray absorptiometry–based hip structural analysis from ACTIVE-J data showed improved hip geometry and biomechanical properties with abaloparatide compared with placebo.

Purpose

Abaloparatide (ABL) increased bone mineral density (BMD) in Japanese patients with osteoporosis at high fracture risk in the ACTIVE-J trial. To evaluate the effect of ABL on hip geometry and biomechanical properties, hip structural analysis (HSA) was performed using ACTIVE-J trial data.

Methods

Hip dual-energy X-ray absorptiometry scans from postmenopausal women and men (ABL, n = 128; placebo, n = 65) at baseline and up to week 78 were analyzed to extract bone geometric parameters at the narrow neck (NN), intertrochanteric region (IT), and proximal femoral shaft (FS). Computed tomography (CT)-based BMD and HSA indices were compared between baseline and week 78.

Results

ABL treatment showed increased mean percent change from baseline to week 78 in cortical thickness at the NN (5.3%), IT (5.3%), and FS (2.9%); cross-sectional area at the NN (5.0%), IT (5.0%), and FS (2.6%); cross-sectional moment of inertia at the NN (7.6%), IT (5.1%), and FS (2.5%); section modulus at the NN (7.4%), IT (5.4%), and FS (2.4%); and decreased mean percent change in buckling ratio (BR) at the IT (− 5.0%). ABL treatment showed increased mean percent change in total volumetric BMD (vBMD; 2.7%) and trabecular vBMD (3.2%) at the total hip and decreased mean percent change in BR at femoral neck (− 4.1%) at week 78 vs baseline. All the changes noted here were significant vs placebo (P < 0.050 using t-test).

Conclusion

A 78-week treatment with ABL showed improvement in HSA parameters associated with hip geometry and biomechanical properties vs placebo.

Trial registration

JAPIC CTI-173575

Abstract Image

使用基于dxa的髋关节结构分析评估阿巴罗肽对日本骨质疏松患者髋关节几何形状和生物力学特性的影响:日本3期ACTIVE-J试验的结果。
在ACTIVE-J试验中,每日皮下注射80 μg阿巴巴拉肽可增加日本骨质疏松症高骨折风险患者的骨密度。基于ACTIVE-J数据的双能x线吸收仪髋关节结构分析显示,与安慰剂相比,阿巴巴拉肽改善了髋关节几何形状和生物力学性能。目的:在ACTIVE-J试验中,阿巴巴拉肽(ABL)可提高日本骨质疏松症高危患者的骨密度(BMD)。为了评估ABL对髋关节几何形状和生物力学性能的影响,使用ACTIVE-J试验数据进行髋关节结构分析(HSA)。方法:绝经后女性和男性(ABL, n = 128;安慰剂组(n = 65)在基线和78周前进行分析,提取窄颈(NN)、粗隆间区(IT)和股骨近端(FS)的骨几何参数。基于CT的BMD和HSA指数在基线和第78周进行比较。结果:ABL治疗显示,从基线到第78周,NN(5.3%)、IT(5.3%)和FS(2.9%)的皮质厚度平均变化百分比增加;NN(5.0%)、IT(5.0%)和FS(2.6%)的横截面积;NN(7.6%)、IT(5.1%)和FS(2.5%)的截面惯性矩;在NN(7.4%)、IT(5.4%)和FS(2.4%)处的截面模量;在IT处,屈曲比(BR)的平均变化百分比降低(- 5.0%)。ABL治疗显示总容积骨密度(vBMD)的平均变化百分比增加;与基线相比,第78周时,全髋关节的骨小梁vBMD(3.2%)和股骨颈BR的平均变化百分比下降(- 4.1%)。此处记录的所有变化与安慰剂相比均具有显著性(使用t检验P < 0.050)。结论:与安慰剂相比,78周ABL治疗显示与髋关节几何形状和生物力学特性相关的HSA参数有所改善。试验注册:JAPIC CTI-173575。
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来源期刊
Archives of Osteoporosis
Archives of Osteoporosis ENDOCRINOLOGY & METABOLISMORTHOPEDICS -ORTHOPEDICS
CiteScore
5.50
自引率
10.00%
发文量
133
期刊介绍: Archives of Osteoporosis is an international multidisciplinary journal which is a joint initiative of the International Osteoporosis Foundation and the National Osteoporosis Foundation of the USA. The journal will highlight the specificities of different regions around the world concerning epidemiology, reference values for bone density and bone metabolism, as well as clinical aspects of osteoporosis and other bone diseases.
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