Comparative analysis of romosozumab and denosumab treatment in hemodialysis patients with osteoporosis: a 12-mo observational study.

This study aimed to evaluate and compare the efficacy and safety of romosozumab vs denosumab in hemodialysis (HD) patients with osteoporosis. A 12-mo observational study was conducted involving HD patients with osteoporosis at a single dialysis center. The study compared outcomes between 2 treatment groups: romosozumab (210 mg monthly,  = 21) and denosumab (60 mg every 6 mo,  = 24). Treatment allocation was based on cardiovascular history. Changes in bone mineral density (BMD), bone turnover markers (P1NP, TRACP-5b, and intact PTH), complications, and fractures were assessed. Serum calcium levels were monitored weekly. After 12 mo, patients receiving romosozumab showed significantly greater improvements in lumbar spine (LS) BMD compared to denosumab (14.6% vs 6.3%,  < .05). Both treatments demonstrated comparable increases in femoral neck (FN) BMD (4.3% vs 6.0%,  = .41). Bone turnover markers showed distinct patterns between groups, with romosozumab producing more pronounced early effects. P1NP levels increased significantly in the romosozumab group at 6 mo (+41.2%) before declining toward baseline, while showing sustained suppression in the denosumab group. The incidence of osteoporotic fractures was one case per group (vertebral fracture in romosozumab group, hip fracture in denosumab group). One case of injection site reactions was observed in the romosozumab group. Mean serum calcium levels remained stable in both groups throughout the study period. The treatment of romosozumab appears to be more effective than denosumab for improving BMD in HD patients with osteoporosis, particularly at the LS. Both treatment approaches demonstrated acceptable safety profiles, though careful monitoring of calcium levels and cardiovascular status is recommended.