Real-world efficacy of a teriparatide biosimilar (RGB-10) compared with reference teriparatide on bone mineral density, trabecular bone score, and bone parameters assessed using quantitative ultrasound, 3D-SHAPER^® and high-resolution peripheral computer tomography in postmenopausal women with osteoporosis and very high fracture risk.

IF 4.2 2区医学 Q1 ENDOCRINOLOGY & METABOLISM Osteoporosis International Pub Date : 2024-12-01 Epub Date: 2024-08-02 DOI:10.1007/s00198-024-07208-z

Peyman Hadji, Luka Kamali, Friederike Thomasius, Konstantin Horas, Andreas Kurth, Nina Bock

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Abstract

A retrospective analysis comparing a teriparatide biosimilar (RGB-10) with reference teriparatide for osteoporosis treatment in postmenopausal women at high fracture risk found them to be therapeutically equivalent. Both provided significant improvements in lumber spine BMD, TBS, and other parameters of bone health, assessed using multiple diagnostic methods.

Purpose: To compare the therapeutic efficacy of a teriparatide biosimilar (RGB-10) with reference teriparatide for the treatment of osteoporosis in postmenopausal women at very high fracture risk.

Methods: A retrospective analysis of 25 postmenopausal female patients treated for osteoporosis with RGB-10 for 24 months and a matched cohort of 25 patients treated with reference teriparatide. The following outcomes were assessed at baseline, 12 and 24 months: bone mineral density (BMD) at the lumbar spine, femoral neck and total hip using dual-energy x-ray absorptiometry (DXA) and integral, trabecular and cortical volumetric and surface BMD using 3D-SHAPER^® imaging, trabecular bone score (TBS), quantitative ultrasound (QUS) measurements, and high-resolution peripheral quantitative computed tomography (HRpQCT) imaging of the radius and tibia.

Results: No significant differences were observed between treatment groups in any of the measured parameters of BMD or bone health at baseline as well as in any timepoint when assessed using these various diagnostic methods. Both compounds provided equivalent significant improvements from baseline in measures of osteoporosis and fracture risk.

Conclusion: The results of the analysis demonstrate the therapeutic equivalence of the teriparatide biosimilar (RGB-10) to reference teriparatide for the treatment of osteoporosis in postmenopausal women at very high risk of fracture.

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使用定量超声波、3D-SHAPER® 和高分辨率外周计算机断层扫描评估骨质疏松症和极高骨折风险绝经后妇女的骨矿物质密度、骨小梁评分和骨参数，特立帕肽生物仿制药（RGB-10）与特立帕肽参考药相比的实际疗效。

一项回顾性分析比较了特立帕肽生物仿制药（RGB-10）与特立帕肽参考药在治疗绝经后高骨折风险妇女骨质疏松症方面的疗效，结果发现两者疗效相当。目的：比较特立帕肽生物仿制药（RGB-10）与特立帕肽对照药治疗骨折风险极高的绝经后妇女骨质疏松症的疗效：对使用 RGB-10 治疗骨质疏松症 24 个月的 25 名绝经后女性患者和使用特立帕肽参照药物治疗的 25 名匹配患者进行回顾性分析。在基线、12 个月和 24 个月时对以下结果进行了评估：腰椎、股骨颈和全髋部的骨矿物质密度（BMD），采用双能 X 射线吸收测定法（DXA）；整体、骨小梁和皮质体积及表面 BMD，采用 3D-SHAPER® 成像；骨小梁评分（TBS）；定量超声波（QUS）测量；桡骨和胫骨的高分辨率外周定量计算机断层扫描（HRpQCT）成像：在使用这些诊断方法进行评估时，治疗组之间在基线和任何时间点的 BMD 或骨健康测量参数上均未见明显差异。在骨质疏松症和骨折风险方面，两种化合物都提供了与基线相当的显著改善：分析结果表明，在治疗骨折风险极高的绝经后妇女的骨质疏松症方面，特立帕肽生物类似物（RGB-10）与参考特立帕肽具有同等疗效。

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来源期刊

Osteoporosis International 医学-内分泌学与代谢

CiteScore

8.10

自引率

10.00%

发文量

224

审稿时长

3 months

期刊介绍： An international multi-disciplinary journal which is a joint initiative between the International Osteoporosis Foundation and the National Osteoporosis Foundation of the USA, Osteoporosis International provides a forum for the communication and exchange of current ideas concerning the diagnosis, prevention, treatment and management of osteoporosis and other metabolic bone diseases. It publishes: original papers - reporting progress and results in all areas of osteoporosis and its related fields; review articles - reflecting the present state of knowledge in special areas of summarizing limited themes in which discussion has led to clearly defined conclusions; educational articles - giving information on the progress of a topic of particular interest; case reports - of uncommon or interesting presentations of the condition. While focusing on clinical research, the Journal will also accept submissions on more basic aspects of research, where they are considered by the editors to be relevant to the human disease spectrum.