Denosumab for treating periprosthetic osteolysis: a feasibility study.

IF 1.6 Q2 MULTIDISCIPLINARY SCIENCES

BMC Research Notes Pub Date : 2025-04-08 DOI:10.1186/s13104-025-07216-0

Michael Axenhus, Henrik Bodén, Paula Kelly-Pettersson, Olof Sköldenberg

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引用次数: 0

Abstract

Objective: Wear-induced osteolysis is a leading cause of late failure in total hip arthroplasty (THA). Denosumab, a RANKL inhibitor, suppresses osteoclast activity and may slow osteolytic progression. This feasibility study aimed to assess the practicality of conducting a randomized, double-blind, placebo-controlled trial evaluating Denosumab's effect on periprosthetic osteolysis in asymptomatic THA patients.

Results: Twelve patients were enrolled; ten completed follow-up. No significant difference in lesion volume change was observed between groups (Denosumab: +1.53 cm³; Placebo: +0.49 cm³). Secondary clinical outcomes also showed no notable differences. The trial protocol, recruitment, treatment, and follow-up were feasible, though slow enrollment limited statistical power. This study demonstrates the feasibility of a larger trial investigating Denosumab for osteolysis prevention.

Trial registration: Clinicaltrails.gov, NCT02299817. Registered 20 November 2014. https://www.

Clinicaltrials: gov/study/NCT02299817?term=Denosumab%20for%20Treating%20Periprosthetic%20Osteolysis.%26;rank=1.

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Denosumab治疗假体周围骨溶解的可行性研究。

目的：磨损性骨溶解是全髋关节置换术晚期失败的主要原因。Denosumab是一种RANKL抑制剂，可抑制破骨细胞活性并可能减缓溶骨进展。本可行性研究旨在评估开展一项随机、双盲、安慰剂对照试验的可行性，以评估Denosumab对无症状THA患者假体周围骨溶解的影响。结果：12例患者入组；10例完成随访。两组间病变体积变化无显著差异(Denosumab: +1.53 cm³；安慰剂：+0.49 cm³)。次要临床结果也无显著差异。试验方案、招募、治疗和随访是可行的，尽管缓慢的招募限制了统计能力。这项研究证明了一项更大规模的研究Denosumab预防骨溶解的试验的可行性。试验注册：Clinicaltrails.gov, NCT02299817。注册于2014年11月20日。https://www.Clinicaltrials gov /研究/ NCT02299817 ?词= Denosumab % 20 % 20治疗% 20 periprosthetic % 20 osteolysis. % 26;等级= 1。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

BMC Research Notes Biochemistry, Genetics and Molecular Biology-Biochemistry, Genetics and Molecular Biology (all)

CiteScore

3.60

自引率

0.00%

发文量

363

审稿时长

15 weeks

期刊介绍： BMC Research Notes publishes scientifically valid research outputs that cannot be considered as full research or methodology articles. We support the research community across all scientific and clinical disciplines by providing an open access forum for sharing data and useful information; this includes, but is not limited to, updates to previous work, additions to established methods, short publications, null results, research proposals and data management plans.