Journal of bone and mineral metabolism · 2026
Comparative effects of roxadustat and epoetin beta on lumbar trabecular BMD in dialysis patients.
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Alaskary Mostafa, Sobh Mohamed A, Fouda Mohamed Ashraf, Rizk Dina Abd Elnasser, Warda Aya Atef, Mortada Wael Ibrahim, Elashmawy Mohamed Maher, Abdalbary Mohamed
Аннотация
INTRODUCTION: Anemia treatment agents may have effects beyond hemoglobin, yet whether hypoxia-inducible factor prolyl hydroxylase inhibition influences bone in dialysis remains uncertain. We compared roxadustat with epoetin beta for lumbar trabecular volumetric bone mineral density (vBMD) measured by quantitative computed tomography (QCT).
MATERIALS AND METHODS: In this single-center, open-label, exploratory randomized trial, 46 adults receiving maintenance hemodialysis were assigned 1:1 to roxadustat or epoetin beta for 6 months. The primary outcome was the baseline-adjusted between-group difference in average lumbar trabecular vBMD at 6 months. Vertebral-level analyses were exploratory.
RESULTS: All participants completed follow-up. Adjusted mean average lumbar vBMD at 6 months was 159 mg/cm3 with roxadustat and 152 mg/cm3 with epoetin beta. The adjusted difference was 7.75 mg/cm3 (95% confidence interval [CI] -10.9 to 26.4; p = 0.406). L1 vBMD was nominally higher with roxadustat (adjusted difference 39.3 mg/cm3, 95% CI 5.2-73.4; p = 0.025), but this finding did not remain statistically significant after multiplicity adjustment (q = 0.124). No significant between-group differences were observed at L2-L5. No adverse events occurred.
CONCLUSION: Roxadustat did not demonstrate superiority over epoetin beta for average lumbar trabecular vBMD over 6 months. These randomized QCT-based estimates address an important evidence gap and may inform larger, longer-term skeletal studies in dialysis.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06917950; registered 27 March 2025.
MATERIALS AND METHODS: In this single-center, open-label, exploratory randomized trial, 46 adults receiving maintenance hemodialysis were assigned 1:1 to roxadustat or epoetin beta for 6 months. The primary outcome was the baseline-adjusted between-group difference in average lumbar trabecular vBMD at 6 months. Vertebral-level analyses were exploratory.
RESULTS: All participants completed follow-up. Adjusted mean average lumbar vBMD at 6 months was 159 mg/cm3 with roxadustat and 152 mg/cm3 with epoetin beta. The adjusted difference was 7.75 mg/cm3 (95% confidence interval [CI] -10.9 to 26.4; p = 0.406). L1 vBMD was nominally higher with roxadustat (adjusted difference 39.3 mg/cm3, 95% CI 5.2-73.4; p = 0.025), but this finding did not remain statistically significant after multiplicity adjustment (q = 0.124). No significant between-group differences were observed at L2-L5. No adverse events occurred.
CONCLUSION: Roxadustat did not demonstrate superiority over epoetin beta for average lumbar trabecular vBMD over 6 months. These randomized QCT-based estimates address an important evidence gap and may inform larger, longer-term skeletal studies in dialysis.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06917950; registered 27 March 2025.