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Short-term efficacy and safety of zoledronate acid or denosumab in Japanese patients with postmenopausal osteoporosis

INTRODUCTION: We aimed to compare the efficacy after switching from either bisphosphonates (BPs) or non-BPs (NBPs) to combination therapies of denosumab (DMAb) or zoledronic acid (Zol) with eldecalcitol (ELD) in bone mineral density (BMD) and bone metabolism and investigate the prognostic and risk f...

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Autores principales: Nakamura, Yumejiro, Shimizu, Tomohiro, Asano, Tsuyoshi, Shimodan, Shun, Ishizu, Hotaka, Takahashi, Daisuke, Takahata, Masahiko, Iwasaki, Norimasa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Singapore 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021003/
https://www.ncbi.nlm.nih.gov/pubmed/33821302
http://dx.doi.org/10.1007/s00774-021-01221-6
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author Nakamura, Yumejiro
Shimizu, Tomohiro
Asano, Tsuyoshi
Shimodan, Shun
Ishizu, Hotaka
Takahashi, Daisuke
Takahata, Masahiko
Iwasaki, Norimasa
author_facet Nakamura, Yumejiro
Shimizu, Tomohiro
Asano, Tsuyoshi
Shimodan, Shun
Ishizu, Hotaka
Takahashi, Daisuke
Takahata, Masahiko
Iwasaki, Norimasa
author_sort Nakamura, Yumejiro
collection PubMed
description INTRODUCTION: We aimed to compare the efficacy after switching from either bisphosphonates (BPs) or non-BPs (NBPs) to combination therapies of denosumab (DMAb) or zoledronic acid (Zol) with eldecalcitol (ELD) in bone mineral density (BMD) and bone metabolism and investigate the prognostic and risk factors of side effects of this therapy. MATERIALS AND METHODS: One-hundred forty-eight patients with postmenopausal osteoporosis were recruited; their therapy was switched from BPs or NBPs to Zol or DMAb plus ELD (BP-Zol: 43, NBP-Zol: 32, BP-DMAb: 35, and NBP-DMAb: 38). Longitudinal changes in bone metabolic markers (P1NP and TRACP-5b) and BMD were evaluated. RESULTS: In the BP-Zol group, P1NP did not change after 6 months and increased by 38.9% after 12 months. TRACP-5b decreased 15.8% after 6 months, but came back to baseline values 12 months after administration. In the rest of the groups, the bone metabolic markers remained suppressed after 6 and 12 months. Compared with baseline, all groups showed increase in BMD after 6 and 12 months. Bone metabolic markers at baseline were correlated with %change in lumbar spine BMD from baseline to 12 months. P1NP and 25-hydroxy vitamin D levels at baseline were identified as potential predictors of development of acute-phase reactions. CONCLUSIONS: The combination therapy of Zol or DMAb and ELD may increase BMD at 12 months after the first administration in Japanese patients with postmenopausal osteoporosis, regardless of BPs pretreatment. Bone metabolic markers at baseline may be useful predictors for reaction to the therapy and side effects caused by these combination therapies in postmenopausal osteoporosis.
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spelling pubmed-80210032021-04-06 Short-term efficacy and safety of zoledronate acid or denosumab in Japanese patients with postmenopausal osteoporosis Nakamura, Yumejiro Shimizu, Tomohiro Asano, Tsuyoshi Shimodan, Shun Ishizu, Hotaka Takahashi, Daisuke Takahata, Masahiko Iwasaki, Norimasa J Bone Miner Metab Original Article INTRODUCTION: We aimed to compare the efficacy after switching from either bisphosphonates (BPs) or non-BPs (NBPs) to combination therapies of denosumab (DMAb) or zoledronic acid (Zol) with eldecalcitol (ELD) in bone mineral density (BMD) and bone metabolism and investigate the prognostic and risk factors of side effects of this therapy. MATERIALS AND METHODS: One-hundred forty-eight patients with postmenopausal osteoporosis were recruited; their therapy was switched from BPs or NBPs to Zol or DMAb plus ELD (BP-Zol: 43, NBP-Zol: 32, BP-DMAb: 35, and NBP-DMAb: 38). Longitudinal changes in bone metabolic markers (P1NP and TRACP-5b) and BMD were evaluated. RESULTS: In the BP-Zol group, P1NP did not change after 6 months and increased by 38.9% after 12 months. TRACP-5b decreased 15.8% after 6 months, but came back to baseline values 12 months after administration. In the rest of the groups, the bone metabolic markers remained suppressed after 6 and 12 months. Compared with baseline, all groups showed increase in BMD after 6 and 12 months. Bone metabolic markers at baseline were correlated with %change in lumbar spine BMD from baseline to 12 months. P1NP and 25-hydroxy vitamin D levels at baseline were identified as potential predictors of development of acute-phase reactions. CONCLUSIONS: The combination therapy of Zol or DMAb and ELD may increase BMD at 12 months after the first administration in Japanese patients with postmenopausal osteoporosis, regardless of BPs pretreatment. Bone metabolic markers at baseline may be useful predictors for reaction to the therapy and side effects caused by these combination therapies in postmenopausal osteoporosis. Springer Singapore 2021-04-05 2021 /pmc/articles/PMC8021003/ /pubmed/33821302 http://dx.doi.org/10.1007/s00774-021-01221-6 Text en © The Japanese Society Bone and Mineral Research 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Original Article
Nakamura, Yumejiro
Shimizu, Tomohiro
Asano, Tsuyoshi
Shimodan, Shun
Ishizu, Hotaka
Takahashi, Daisuke
Takahata, Masahiko
Iwasaki, Norimasa
Short-term efficacy and safety of zoledronate acid or denosumab in Japanese patients with postmenopausal osteoporosis
title Short-term efficacy and safety of zoledronate acid or denosumab in Japanese patients with postmenopausal osteoporosis
title_full Short-term efficacy and safety of zoledronate acid or denosumab in Japanese patients with postmenopausal osteoporosis
title_fullStr Short-term efficacy and safety of zoledronate acid or denosumab in Japanese patients with postmenopausal osteoporosis
title_full_unstemmed Short-term efficacy and safety of zoledronate acid or denosumab in Japanese patients with postmenopausal osteoporosis
title_short Short-term efficacy and safety of zoledronate acid or denosumab in Japanese patients with postmenopausal osteoporosis
title_sort short-term efficacy and safety of zoledronate acid or denosumab in japanese patients with postmenopausal osteoporosis
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021003/
https://www.ncbi.nlm.nih.gov/pubmed/33821302
http://dx.doi.org/10.1007/s00774-021-01221-6
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