Real-world outcomes of denosumab treatment in patients undergoing hemodialysis for osteoporosis: A 3-year observational study

OBJECTIVE: The safety and efficacy of denosumab in patients undergoing hemodialysis for osteoporosis remain underexplored. Therefore, guidelines are unclear regarding whether denosumab can be safely used in these patients. This study aimed to present the experience of denosumab treatment in a small cohort of patients for up to 3 years. MATERIALS AND METHODS: This study evaluated the effects of denosumab on bone metabolism in 12 patients with end-stage kidney disease (ESKD) and osteoporosis undergoing long-term hemodialysis in an observational cohort setting. These patients were maintained on high doses of calcium carbonate (1,250 mg/day) and vitamin D (1,000 IU/day) supplementation during denosumab treatment to prevent hypocalcemia. Eleven patients with ESKD undergoing hemodialysis who did not receive osteoporosis treatment were followed for the same period as a control group. Changes in biochemical markers, bone mineral density (BMD), and clinical outcomes were analyzed over a 3-year follow-up period. RESULTS: The results revealed no significant differences in lumbar spine BMD but indicated a trend toward high femoral BMD values in the denosumab treatment group at the 2- and 3-year follow-up points. However, 2 patients experienced severe hypocalcemia. Most cases of denosumab discontinuation were due to a lack of BMD improvement. CONCLUSION: These findings highlight the potential of denosumab in managing osteoporosis in patients undergoing hemodialysis but also underscore the need for careful monitoring of calcium levels to mitigate adverse effects. Therefore, adequate calcium replacement is required to prevent severe hypocalcemia. This study provides valuable real-world evidence to guide therapeutic strategies for improving bone health in patients with ESKD.