Trial reportActa orthopaedica2026
Denosumab and bone loss in uncemented total hip arthroplasty: a secondary 5-year follow-up of a randomized controlled trial.
Trial report in Acta orthopaedica, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01630941 (Uncemented Total Hip Implant and Subcutaneous Injections of Denosumab for Patients With Osteoarthritis of the Hip. A Randomized Double Blind Placebo Controlled Study on the Effects on Bone Evaluated With DXA, PET/CT and Biochemical Markers), which is not on this map. Not yet cited in PubMed.
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Uncemented Total Hip Implant and Subcutaneous Injections of Denosumab for Patients With Osteoarthritis of the Hip. A Randomized Double Blind Placebo Controlled Study on the Effects on Bone Evaluated With DXA, PET/CT and Biochemical Markers
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3 authors.
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Abstract
background and purposeDenosumab may preserve periprosthetic bone mineral density (pBMD) around uncemented total hip arthroplasty (THA) components. This exploratory analysis of a previously published randomized controlled trial (RCT) aimed to assess the effects of denosumab on BMD 5 years after treatment cessation.
methods64 non-osteoporotic patients undergoing uncemented THA were enrolled in a randomized, double-blind, placebo-controlled phase-2 trial and received either 2 doses of denosumab or placebo. The primary outcome was pBMD at 12 months, measured by dual-energy X-ray absorptiometry (DEXA). At a mean follow-up of 5.6 years (range 4.3-7.3), 54 patients remained for clinical assessment, DEXA, and plain radiography. The study was registered on ClinicalTrials.gov (NCT01630941).
resultsNo differences in pBMD in the acetabular Digas zones or femoral Gruen zones were found between the groups at 5 years. The estimated mean difference in the sum of all zones around the cup was 0.042 g/cm² (95% confidence interval [CI] -0.31 to 0.35; P = 0.8), and for the sum of all Gruen zones -0.06 g/cm² (CI -0.55 to 0.43; P = 0.8). No statistically significant differences were observed in patient-reported outcome measures or the incidence of heterotopic ossification. A gradual decline in pBMD was evident.
conclusionAt 5 years, the adjusted between-group difference and its 95% confidence interval showed no statistically or clinically relevant effect of denosumab. Whether longer treatment duration or a sequential post-denosumab regimen could influence long-term periprosthetic bone preservation is unknown.
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