A target trial emulation evaluated the incidence of emergently treated hypoalcemia associated with denosumab by stage of chronic kidney disease (CKD) progression and presence of CKD-mineral and bone disorder (CKD-MBD).
The data revealed that the risk of emergently treated hypocalcemia increased with worsening CKD stage, with dialysis-dependent patients and those with CKD-MBD at the highest risk. The study is published in Annals of Internal Medicine.
Researchers from the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) studied data for female Medicare beneficiaries aged 65 years and older with CKD initiating denosumab, oral bisphosphonates, or intravenous bisphosphonates for osteoporosis between 2012 to 2020. The authors sought to assess the risk for emergently treated hypocalcemia with denosumab by stage of CKD and presence of CKD-MBD. The researchers found that increased risk of emergently treated hypocalcemia with denosumab appeared within 1 week after denosumab administration, peaked at week 2 and persisted for approximately 10 weeks, compared with oral bisphosphonates. As CKD stage progressed, so did the risk of denosumab-induced emergently treated hypocalcemia, with a notable increased risk for both non-dialysis dependent and dialysis dependent patients with late-stage CKD. Among those with late-stage CKD, those with CKD-MBD were at a greater risk for emergently treated hypocalcemia with denosumab vs. oral bisphosphonates. Denosumab also showed increased risk compared to intravenous bisphosphonates. According to the researchers, there is a scarcity of data on the treatment of osteoporosis in patients with advanced CKD, despite osteoporosis and CKD being common comorbidities.
