Abstract
Evidence for the efficacy of denosumab in HD patients is limited. Accordingly, here we report a study on the safety and efficacy of denosumab in these patients. We prospectively followed 324 patients (121 HD and 203 non-HD patients) receiving denosumab between June 2013 and May 2018, assessing changes in bone mineral density (BMD) and bone metabolic markers, and noting side-effects. Annual changes in BMD at the lumbar spine in HD and non-HD patients from baseline were, respectively, 6.7 ± 11.1% and 7.5 ± 10.2% (p = 0.60), those at the femoral neck were 4.3 ± 7.9% and 3.1 ± 9.5% (p = 0.32), and those at the distal radius were −0.5 ± 6.4% and 0.2 ± 13.0% (p = 0.66). The prevalence of hypocalcemia (<8.5 mg/dL) was significantly higher in HD than in non-HD patients (35.6% vs 5.4%, p < 0.001). The median elapsed time between the first injection of denosumab and the occurrence of hypocalcemia was 7 days in HD patients. The decrease of serum calcium was greater in patients with higher TRACP5b, corticosteroid use, and those without CaCO3 supplementation. Our study suggests that denosumab was equally as effective in HD as non-HD patients. However, careful hypocalcemia monitoring, for at least 4 weeks, is recommended for HD patients.
Highlights
Evidence for the efficacy of denosumab in HD patients is limited
Superior efficacy of denosumab, a human monoclonal antibody to the receptor activator of nuclear factor kappa-B ligand (RANKL), for the treatment of osteoporosis in the general population has been reported. This followed many studies suggesting that denosumab could increase bone mineral density (BMD) and decrease the risk of bone fractures in both men and women with osteoporosis who are at high risk of fracture[4,5,6]
After adjusting for age, sex, body mass index, dialysis vintage, tP1NP, intact parathyroid hormone (iPTH), use of active vitamin D, CaCO3, bisphosphonates, cinacalcet, and corticosteroid, we found that the highest quartile of TRACP5b was associated with a large decrease of calcium in model 1 when using the lowest quartile as the reference (HR 3.93 [1.51, 10.24]) (Table 4)
Summary
Evidence for the efficacy of denosumab in HD patients is limited. here we report a study on the safety and efficacy of denosumab in these patients. It has been reported that the incidence of bone fracture among HD patients is 5–6 times higher than in the general population[1]. Superior efficacy of denosumab, a human monoclonal antibody to the receptor activator of nuclear factor kappa-B ligand (RANKL), for the treatment of osteoporosis in the general population has been reported. This followed many studies suggesting that denosumab could increase bone mineral density (BMD) and decrease the risk of bone fractures in both men and women with osteoporosis who are at high risk of fracture[4,5,6]. We launched a prospective cohort study to analyze the efficacy and safety of the drug, and to identify the factors associated with hypocalcemia after drug initiation
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