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Randomized Controlled Trial
. 2025 Apr 8;18(1):151.
doi: 10.1186/s13104-025-07216-0.

Denosumab for treating periprosthetic osteolysis: a feasibility study

Michael Axenhus  1   2 , Henrik Bodén  3   4 , Paula Kelly-Pettersson  3   4 , Olof Sköldenberg  3   4
Affiliations
Randomized Controlled Trial

Denosumab for treating periprosthetic osteolysis: a feasibility study

Michael Axenhus et al. BMC Res Notes. .

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.

Keywords: Computed tomography; Denosumab; Osteolysis; Outcome; Randomized controlled trial; Total hip arthroplasty.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The Ethics Committee of the Karolinska Institute and the Swedish Medical Products Agency approved the study. Individual consent was obtained from each patient. The trial is registered at ClinicalTrials.gov (NCT02299817), registered 20th of November 2014. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram
Fig. 2
Fig. 2
Mean volume change in osteolytic lesions at 3 years follow up. Error bars indicate 95% CI
Fig. 3
Fig. 3
Mean volume change of osteolysis lesions during 2 and 3 years follow up
See this image and copyright information in PMC

References

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