Comparative effects of roxadustat and epoetin beta on lumbar trabecular BMD in dialysis patients

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).

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.

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.

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.

ClinicalTrials.gov NCT06917950; registered 27 March 2025.