Risk increased with worsening CKD stage with denosumab versus bisphosphonates; highest risk seen for dialysis-dependent CKD, CKD-mineral and bone disorder<\/p>\n<\/h3>\n
By Elana Gotkine HealthDay Reporter<\/b>
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TUESDAY, Nov. 19, 2024 (HealthDay News) — For patients with chronic kidney disease (CKD), the risk for emergently treated hypocalcemia with denosumab increases with worsening CKD stage, according to a study published online Nov. 19 in the Annals of Internal Medicine<\/em>.<\/p>\n Steven T. Bird, Ph.D., Pharm.D., from the U.S. Food and Drug Administration in Silver Spring, Maryland, and colleagues conducted a target trial emulation to examine the risk for emergently treated hypocalcemia with denosumab by stage of CKD and presence of CKD-mineral and bone disorder (MBD) among female patients aged 65 years or older. Participants initiated denosumab (361,453 patients), oral bisphosphonates (829,044 patients), or intravenous bisphosphonates (160,413 patients) for osteoporosis.<\/p>\n The researchers found that with denosumab versus oral bisphosphonates, the risk for emergently treated hypocalcemia increased with worsening CKD stage, with the highest risk seen among dialysis-dependent patients (3.01 versus 0.0 percent) and non-dialysis-dependent patients with CKD stages 4 and 5 (0.57 versus 0.03 percent). Among patients with stages 4 and 5 CKD, denosumab exhibited a higher risk for emergently treated hypocalcemia versus oral bisphosphonates in those with CKD-MBD (1.53 versus 0.02 percent) than in those without CKD-MBD (0.22 versus 0.03 percent). Increased risk was also seen for denosumab versus intravenous bisphosphonates.<\/p>\n “The highest incidence was seen in patients with advanced CKD and those with CKD-MBD,” the authors write. “Diagnosis and management of skeletal fragility in these high-risk patients is complex, requiring careful patient selection, adequate supplementation with calcium and vitamin D, and frequent monitoring of serum calcium under supervision of a clinician with expert knowledge and experience treating CKD-MBD.”<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n