Denosumab for treating periprosthetic osteolysis: a feasibility study

Area of Science:

• Orthopedic surgery
• Biomedical engineering
• Pharmacology

Background:

• Wear-induced osteolysis is a primary cause of late failure in total hip arthroplasty (THA).
• Denosumab, a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor, is investigated for its potential to mitigate osteoclast activity and slow osteolytic progression.
• A feasibility study was conducted to assess the practicality of a larger randomized controlled trial.

Purpose of the Study:

• To evaluate the feasibility of a randomized, double-blind, placebo-controlled trial.
• To assess the effect of Denosumab on periprosthetic osteolysis in asymptomatic THA patients.
• To determine the practicality of Denosumab for preventing osteolytic progression.

Main Methods:

• A randomized, double-blind, placebo-controlled feasibility study.
• Enrollment of asymptomatic THA patients.
• Assessment of lesion volume change and secondary clinical outcomes.

Main Results:

• Twelve patients were enrolled, with ten completing the study.
• No statistically significant difference in lesion volume change was observed between the Denosumab and placebo groups.
• The trial protocol, recruitment, treatment, and follow-up were deemed feasible, despite slow enrollment impacting statistical power.

Conclusions:

• The study demonstrated the feasibility of conducting a larger clinical trial on Denosumab for osteolysis prevention.
• While not statistically significant in this small cohort, the findings support further investigation into Denosumab's role in managing periprosthetic osteolysis.
• Further research is warranted to confirm the efficacy of Denosumab in larger patient populations.