Denosumab Prevents Early Periprosthetic Bone Loss After Uncemented Total Hip Arthroplasty: Results from a Randomized Placebo-Controlled Clinical Trial.

研究概要

Sixty-four patients scheduled for an uncemented total hip arthroplasty (THA) were randomized to receive either two doses of denosumab or placebo administered following completion of the procedure and 6 months post-operation. The primary outcomes of interest were bone mineral density (BMD) at Gruen zone 7 and the sum of BMDs in Gruen zones 1-7. Secondary outcomes of interest included standard uptake volume (SUV) at Gruen zone 7 and the sum of SUVs in Gruen zones 1-7, levels of S-C-telopeptide of type 1 collagen (CTX) and S-procollagen type 1 N-terminal propeptide (P1NP), Harris Hip Scores (HHS) and EQ-Visual Analog Scale (EQ-VAS). Outcomes were measured up to 24 months post-treatment. Study results revealed higher BMD in Gruen zone 7 and sum of BMDs in Gruen zones 1-7 in the denosumab group. SUV at Gruen zone 7 and sum of SUVs in Gruen zones 1-7 were 32% and 37% lower in the denosumab group, respectively, at 3 months post-operation. CTX and P1NP levels were lower in the denosumab group initially, however at 24 months both were higher in the denosumab group compared to the placebo group. No significant differences in EQ-VAS scores were observed between the two groups at all time-points. HHS scores at 12 months were significantly higher in the placebo group compared to the denosumab group.