Denosumab for dialysis patients with osteoporosis: A cohort study
Kyohei Kunizawa1,2, Rikako Hiramatsu1, Junichi Hoshino3,4,5
1Nephrology Center, Toranomon Hospital Kajigaya, Kanagawa, Japan.
Insights
Denosumab showed similar bone mineral density improvements in hemodialysis (HD) and non-HD patients. However, HD patients had a higher risk of hypocalcemia, requiring careful monitoring post-treatment.
Area of Science:
- Nephrology
- Endocrinology
- Bone Metabolism
Background:
- Limited evidence exists on denosumab's efficacy in hemodialysis (HD) patients.
- Denosumab is a monoclonal antibody targeting RANKL, used for osteoporosis and bone metastases.
Purpose of the Study:
- To evaluate the safety and efficacy of denosumab in HD patients compared to non-HD patients.
- To assess changes in bone mineral density (BMD) and bone metabolic markers.
- To identify potential side effects, particularly hypocalcemia.
Main Methods:
- Prospective study of 324 patients (121 HD, 203 non-HD) receiving denosumab from June 2013 to May 2018.
- Assessed annual changes in BMD at lumbar spine, femoral neck, and distal radius.
- Monitored bone metabolic markers and adverse events, focusing on hypocalcemia.
Main Results:
- No significant difference in annual BMD changes between HD and non-HD patients at lumbar spine, femoral neck, or distal radius.
- Significantly higher prevalence of hypocalcemia in HD patients (35.6%) compared to non-HD patients (5.4%).
- Hypocalcemia in HD patients occurred median 7 days post-injection; greater calcium decrease observed with higher TRACP5b, corticosteroid use, and no CaCO3 supplementation.
Conclusions:
- Denosumab demonstrates comparable efficacy in improving BMD for both HD and non-HD patients.
- HD patients require vigilant hypocalcemia monitoring for at least 4 weeks after denosumab administration.
- Risk factors for hypocalcemia in HD patients include higher TRACP5b, corticosteroid use, and lack of calcium supplementation.
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.
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