Efficacy of romosozumab in patients with osteoporosis on maintenance hemodialysis in Japan; an observational study.

Abstract

Romosozumab reportedly increases bone mineral density (BMD) potently but might adversely affect cardiovascular disease (CVD). We evaluated the efficacy of romosozumab in osteoporotic HD patients with a high risk of fracture. This was a single-center 1-year study in Japanese HD patients. Among 96 HD romosozumab-treated HD patients with high risk of fracture, 76 HD patients completed 1year of subcutaneous administration of romosozumab (210mg/4weeks) for 1year. Romosozumab-untreated HD patients (n = 55) were also included. Changes in BMD and serum markers, together with fracture occurrence, and CVD events, were monitored. During romosozumab treatment of 76 HD patients, BMD time-dependently increased significantly by 15.3% ± 12.9% at the lumbar spine (L1-4), and 7.2% ± 8.3% at the femoral neck at 1year. Serum BAP and total P1NP increased significantly and serum TRACP-5b decreased at 4weeks. Fragility fractures occurred in three (3.8%) patients. Hypocalcemia occurred at 4-48weeks despite the increased dosing of active vitamin-D derivatives, but without any symptom. New CVD events occurred in 5.2% of romosozumab-treated HD patients and10.9% in romosozumab-untreated HD patients. BMD was increased significantly during romosozumab treatment at the lumbar spine, and the femoral neck, respectively, at 1year in HD patients. Hypocalcemia occurred but without any intolerable event. There was no apparent increase in CVD events during 1year of study, suggesting romosozumab as a promising agent for HD patients with severe osteoporosis.