國家衛生研究院 NHRI:Item 3990099045/15432

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Title:	Zoledronate as a preventative measure for bone loss following denosumab discontinuation: Results from a multi-institutional randomized controlled trial
Authors:	Fu, SH;Lee, CC;Hung, CC;Li, CY;Wang, CY
Contributors:	National Center for Geriatrics and Welfare Research
Abstract:	Objective: The discontinuation of denosumab for the treatment ofosteoporosis can result in a rebound effect, characterized by a signiﬁcant loss of bone mineral density (BMD) and an increased risk of vertebral fractures. This prospective multi-institutional randomized controlled trial aims to investigate whether zoledronate can prevent BMD loss after denosumab discontinuation in patients who have been receiving denosumab treatment for two or more years. Materials and methods: A total of 101 patients, including 95 females and 6 males with an average age of 70.9 years, were recruited for the study. Participants were stratiﬁed into 4 groups and received either regular denosumab therapy (group 1) or zoledronate treatment in the ﬁrst year followed by on-time denosumab (group 2), on-time zoledronate (group 3), or drug holiday (group 4) in the second year. BMD and bone turnover markers (BTMs) were measured at baseline and annually thereafter. To facilitate the analysis of ﬁrst-year results, we combined groups 2, 3, and 4 since all of them received zoledronate treatment in the ﬁrst year, and compared them with group 1. Results: After one year, patients receiving continuous denosumab therapy had a signiﬁcant increase in vertebral BMD compared to those receiving zoledronate treatment in the ﬁrst year (2.07 ± 0.80% vs 0.64 ± 0.58%, p = 0.02). The difference in BMD loss was more pronounced in patients who had received denosumab for C 3 years compared to those treated for B 2.5 years (- 3.94 ± 1.60% vs. 0.45 ± 1.87%, p = 0.03). Low body weight was also identiﬁed as a risk factor for decreased BMD. Changes in P1NP were more sensitive to changes in bone metabolism indicators than CTX. Conclusions: The study results suggest that the duration of deno-sumab treatment affects the efﬁcacy of sequential treatment with zoledronate, with signiﬁcantly greater BMD loss observed in patients receiving denosumab for C 3 years compared to those treated for B 2.5 years. P1NP may be a leading indicator for deciding to add another zoledronate when monitoring BTMs. These ﬁndings align with the recommendation of the European Calciﬁed Tissue Society.
Date:	2023-07-21
Relation:	Aging Clinical and Experimental Research. 2023 Jul 21;35:S72.
Link to:	http://dx.doi.org/10.1007/s40520-023-02442-7
JIF/Ranking 2023:	http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1594-0667&DestApp=IC2JCR
Cited Times(WOS):	https://www.webofscience.com/wos/woscc/full-record/WOS:001058500200074
Appears in Collections:	[Chen-Yu Wang] Conference Papers/Meeting Abstract

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