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Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_2 | Pages 90 - 90
1 Mar 2021
Mahatma M Jayasuriya R Gossiel F Gallagher O Hughes D Buckley S Gordon A Hamer A Tomouk M Wilkinson JM
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Abstract

Objective

In this phase 2 clinical trial (EudraCT 2011-000541-20) we examined the effect of denosumab versus placebo on osteolytic lesion activity in patients undergoing revision surgery after THA.

Methods

Men and women ≥ 30 years old scheduled for revision surgery for symptomatic, radiologically-confirmed osteolysis were randomised (1:1) to receive either denosumab 60mg or placebo subcutaneously eight weeks prior to operation. At surgery, biopsies from the osteolytic membrane-bone interface were taken for histomorphometric analysis of osteoclast number, the primary outcome measure. Secondary outcome measures included other static histomorphometric indices and systemic bone turnover markers. Adverse events and patient-reported clinical outcome scores were recorded as safety endpoints.