| 초록 |
Objectives: Chronic kidney disease (CKD) is a well-known risk factor for osteoporosis and fractures, but treatment options are very limited in these patients. Although Denosumab is a bone anti-resorptive drug that can be considered in dialysis patients, small RCTs (randomized controlled trial) and observational studies have shown some benefits, data on efficacy is still lacking. Therefore, this study aims to evaluate the safety and efficacy of denosumab in hemodialysis (HD) patients with osteoporosis. Methods: We retrospectively analyzed 91 HD patients with osteoporosis received denosumab more than twice every 6 months between August 2018 and March 2023. Before each administration, biochemical markers including calcium, phosphate, parathyroid hormone and bone turnover markers are confirmed. Blood samples are taken every 3-5 days for two weeks after administration to monitor the occurrence of hypocalcemia, and changes in PTH over two months are measured. Results: The average age was 73.3 ±10.4 years, with 25 males (27.5%) and 51 diabetic patients (56.0%). Baseline BMDs at the lumbar spine and femur neck were -2.2 ± 1.1 and -2.7 ± 0.7, respectively. One year after denosumab administration, there was a significant increase in BMD at lumbar spine (-2.2 ± 1.1 and -1.9 ± 1.0, p<0.001), but not in femur neck BMD (-2.73 ± 0.73 and 2.66 ± 0.82, P=0.08). Increases in BMD at the lumbar spine and femur neck from baseline were observed in 79.4% and 62.7 % of patients, respectively. Although serum level of calcium significantly decreased after administration of denosumab, none of the patients experienced severe hypocalcemia or jaw osteonecrosis. Conclusions: Our results suggests that denosumab can significantly increase BMD in HD patients without serious side effects. However, since this study did not evaluate effectiveness for fracture prevention or conduct long-term follow-up observations, further research is necessary. |