Scholarlink

Objective <p>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.</p> Results <p>Twelve patients were enrolled; ten completed follow-up. No significant difference in lesion volume change was observed between groups (Denosumab: +1.53&#xa0;cm³; Placebo: +0.49&#xa0;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.</p> Trial registration <p>Clinicaltrails.gov, NCT02299817. Registered 20 November 2014. <a href="https://www.clinicaltrials.gov/study/NCT02299817?term=Denosumab%20for%20Treating%20Periprosthetic%20Osteolysis.%26;rank=1">https://www.clinicaltrials.gov/study/NCT02299817?term=Denosumab%20for%20Treating%20Periprosthetic%20Osteolysis.%26;rank=1</a></p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Denosumab for treating periprosthetic osteolysis: a feasibility study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年4月8日

查看全文
  • Michael Axenhus,
  • Henrik Bodén,
  • Paula Kelly-Pettersson,
  • Olof Sköldenberg

摘要

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