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Changes in BMD T-score from pre-to post-treatment with biosimilar teriparatide: A single-arm, multi-center study

INTRODUCTION: Teriparatide is a recombinant analog of the parathyroid hormone and an anabolic treatment modality for osteoporosis. This study aimed to evaluate the effectiveness of biosimilar teriparatide (CinnoPar®, CinnaGen Co., Iran) in osteoporotic patients after at least one year of treatment....

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Autores principales: Soroush, Mohsen G., Kheirandish, Maryam, Soroosh, Soosan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10245092/
https://www.ncbi.nlm.nih.gov/pubmed/37293390
http://dx.doi.org/10.1016/j.bonr.2023.101689
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author Soroush, Mohsen G.
Kheirandish, Maryam
Soroosh, Soosan
author_facet Soroush, Mohsen G.
Kheirandish, Maryam
Soroosh, Soosan
author_sort Soroush, Mohsen G.
collection PubMed
description INTRODUCTION: Teriparatide is a recombinant analog of the parathyroid hormone and an anabolic treatment modality for osteoporosis. This study aimed to evaluate the effectiveness of biosimilar teriparatide (CinnoPar®, CinnaGen Co., Iran) in osteoporotic patients after at least one year of treatment. METHODS: In this multi-center, single-arm study, 239 eligible patients received subcutaneous injections of biosimilar teriparatide 20 μg once daily for at least one year. The main outcome measure was the change in bone mineral density (BMD) T-score from baseline (pre-treatment) to end of the study (post-treatment). In addition, the change in the fracture risk assessment tool (FRAX) score was calculated to estimate the 10-year probability of major and hip fractures pre-and post-treatment. RESULTS: A total of 239 patients (age, 63 ± 12.14 years; female, 88.28 %) were included, of which 27.62 % (66/239), 14.64 % (35/239), and 57.74 % (138/239) received biosimilar teriparatide for 12–16 months, 17–20 months, and 21–24 months, respectively. From baseline to end of the study, the T-score at the lumbar spine increased from −2.67 ± 1.04 to −2.26 ± 1.11 (mean percent change, 13.07 ± 62.89; p-value<0.001). Similarly, the T-score at femoral neck increased from −2.18 ± 0.87 to −2.09 ± 0.93 (mean percent change, 3.81 ± 31.52; p-value = 0.006). The proportions of patients with maintained or improved BMD T-score at the lumbar spine and femoral neck sites were 85.36 % (204/239) and 69.04 % (165/239), respectively. Similar results were obtained in subgroups of patients with rheumatoid arthritis and those with a history of a previous fracture or parental hip fracture. FRAX scores did not change significantly during the study (p-values of 0.551 and 0.973 at the lumbar spine and femoral neck, respectively). CONCLUSION: We observed considerable improvements in BMD following treatment with the biosimilar teriparatide for one year or more. The biosimilar teriparatide can be considered as an effective treatment option in female and male patients with osteoporosis.
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spelling pubmed-102450922023-06-08 Changes in BMD T-score from pre-to post-treatment with biosimilar teriparatide: A single-arm, multi-center study Soroush, Mohsen G. Kheirandish, Maryam Soroosh, Soosan Bone Rep Full Length Article INTRODUCTION: Teriparatide is a recombinant analog of the parathyroid hormone and an anabolic treatment modality for osteoporosis. This study aimed to evaluate the effectiveness of biosimilar teriparatide (CinnoPar®, CinnaGen Co., Iran) in osteoporotic patients after at least one year of treatment. METHODS: In this multi-center, single-arm study, 239 eligible patients received subcutaneous injections of biosimilar teriparatide 20 μg once daily for at least one year. The main outcome measure was the change in bone mineral density (BMD) T-score from baseline (pre-treatment) to end of the study (post-treatment). In addition, the change in the fracture risk assessment tool (FRAX) score was calculated to estimate the 10-year probability of major and hip fractures pre-and post-treatment. RESULTS: A total of 239 patients (age, 63 ± 12.14 years; female, 88.28 %) were included, of which 27.62 % (66/239), 14.64 % (35/239), and 57.74 % (138/239) received biosimilar teriparatide for 12–16 months, 17–20 months, and 21–24 months, respectively. From baseline to end of the study, the T-score at the lumbar spine increased from −2.67 ± 1.04 to −2.26 ± 1.11 (mean percent change, 13.07 ± 62.89; p-value<0.001). Similarly, the T-score at femoral neck increased from −2.18 ± 0.87 to −2.09 ± 0.93 (mean percent change, 3.81 ± 31.52; p-value = 0.006). The proportions of patients with maintained or improved BMD T-score at the lumbar spine and femoral neck sites were 85.36 % (204/239) and 69.04 % (165/239), respectively. Similar results were obtained in subgroups of patients with rheumatoid arthritis and those with a history of a previous fracture or parental hip fracture. FRAX scores did not change significantly during the study (p-values of 0.551 and 0.973 at the lumbar spine and femoral neck, respectively). CONCLUSION: We observed considerable improvements in BMD following treatment with the biosimilar teriparatide for one year or more. The biosimilar teriparatide can be considered as an effective treatment option in female and male patients with osteoporosis. Elsevier 2023-05-25 /pmc/articles/PMC10245092/ /pubmed/37293390 http://dx.doi.org/10.1016/j.bonr.2023.101689 Text en © 2023 Published by Elsevier Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Full Length Article
Soroush, Mohsen G.
Kheirandish, Maryam
Soroosh, Soosan
Changes in BMD T-score from pre-to post-treatment with biosimilar teriparatide: A single-arm, multi-center study
title Changes in BMD T-score from pre-to post-treatment with biosimilar teriparatide: A single-arm, multi-center study
title_full Changes in BMD T-score from pre-to post-treatment with biosimilar teriparatide: A single-arm, multi-center study
title_fullStr Changes in BMD T-score from pre-to post-treatment with biosimilar teriparatide: A single-arm, multi-center study
title_full_unstemmed Changes in BMD T-score from pre-to post-treatment with biosimilar teriparatide: A single-arm, multi-center study
title_short Changes in BMD T-score from pre-to post-treatment with biosimilar teriparatide: A single-arm, multi-center study
title_sort changes in bmd t-score from pre-to post-treatment with biosimilar teriparatide: a single-arm, multi-center study
topic Full Length Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10245092/
https://www.ncbi.nlm.nih.gov/pubmed/37293390
http://dx.doi.org/10.1016/j.bonr.2023.101689
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