BMC research notes · 2025
Denosumab for treating periprosthetic osteolysis: a feasibility study.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Axenhus Michael, Bodén Henrik, Kelly-Pettersson Paula, Sköldenberg Olof
Аннотация
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.
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.