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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

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Title: 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
Authors: Peyman Hadji, Luka Kamali, Friederike Thomasius, Konstantin Horas, Andreas Kurth, Nina Bock
Source: Osteoporos Int
Publisher Information: Springer Science and Business Media LLC, 2024.
Publication Year: 2024
Subject Terms: Aged, 80 and over, Lumbar Vertebrae, Bone Density Conservation Agents, Femur Neck, Middle Aged, Absorptiometry, Photon, Treatment Outcome, Imaging, Three-Dimensional, Bone Density, Teriparatide, Absorptiometry, Photon/methods [MeSH], Aged, 80 and over [MeSH], Osteoporotic Fractures/physiopathology [MeSH], Aged [MeSH], Osteoporosis, Postmenopausal/diagnostic imaging [MeSH], Osteoporosis, Postmenopausal/drug therapy [MeSH], Tomography, X-Ray Computed/methods [MeSH], Biosimilar Pharmaceuticals/pharmacology [MeSH], Cancellous Bone/diagnostic imaging [MeSH], Biosimilar Pharmaceuticals/administration, Osteoporosis, Postmenopausal/physiopathology [MeSH], Original Article, Bone Density Conservation Agents/therapeutic use [MeSH], Cancellous Bone/physiopathology [MeSH], Lumbar Vertebrae/physiopathology [MeSH], Biosimilar Pharmaceuticals/therapeutic use [MeSH], Imaging, Three-Dimensional/methods [MeSH], Lumbar Vertebrae/diagnostic imaging [MeSH], Biosimilar, Fracture, Teriparatide/pharmacology [MeSH], Female [MeSH], Bone Density Conservation Agents/administration, Bone Density/drug effects [MeSH], Ultrasonography/methods [MeSH], Humans [MeSH], Treatment Outcome [MeSH], HRpQCT, Retrospective Studies [MeSH], Femur Neck/physiopathology [MeSH], Middle Aged [MeSH], Osteoporosis, Osteoporotic Fractures/prevention, Bone Density Conservation Agents/pharmacology [MeSH], BMD, Teriparatide/therapeutic use [MeSH], Teriparatide/administration, Cancellous Bone/drug effects [MeSH], Osteoporotic Fractures/diagnostic imaging [MeSH], Cancellous Bone, Humans, Female, Tomography, X-Ray Computed, Biosimilar Pharmaceuticals, Osteoporotic Fractures, Osteoporosis, Postmenopausal, Aged, Retrospective Studies, Ultrasonography
Description: 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.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.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.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.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.
Document Type: Article
Other literature type
Language: English
ISSN: 1433-2965
0937-941X
DOI: 10.1007/s00198-024-07208-z
Access URL: https://pubmed.ncbi.nlm.nih.gov/39093439
https://repository.publisso.de/resource/frl:6520057
Rights: CC BY NC
URL: http://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (http://creativecommons.org/licenses/by-nc/4.0/) .
Accession Number: edsair.doi.dedup.....840f2439fd805ab7931e22ecac93a1fa
Database: OpenAIRE
Description
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.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.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.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.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.
ISSN:14332965
0937941X
DOI:10.1007/s00198-024-07208-z