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01-09-2021 | Bisphosphonate | Original Article

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

Authors: Yumejiro Nakamura, Tomohiro Shimizu, Tsuyoshi Asano, Shun Shimodan, Hotaka Ishizu, Daisuke Takahashi, Masahiko Takahata, Norimasa Iwasaki

Published in: Journal of Bone and Mineral Metabolism | Issue 5/2021

Abstract

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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Title: Short-term efficacy and safety of zoledronate acid or denosumab in Japanese patients with postmenopausal osteoporosis
Authors: Yumejiro Nakamura
Tomohiro Shimizu
Tsuyoshi Asano
Shun Shimodan
Hotaka Ishizu
Daisuke Takahashi
Masahiko Takahata
Norimasa Iwasaki
Publication date: 01-09-2021
Publisher: Springer Singapore
Keywords: Bisphosphonate
Osteoporosis
Osteoporosis
Hypocalcemia
Denosumab
Zoledronic Acid
Denosumab
Published in: Journal of Bone and Mineral Metabolism / Issue 5/2021
Print ISSN: 0914-8779
Electronic ISSN: 1435-5604
DOI: https://doi.org/10.1007/s00774-021-01221-6

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Abstract

Introduction

Materials and methods

Results

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