Denosumab treatment for osteoporosis raises the risk for hypocalcemia, which worsens with advancing stages of chronic kidney disease (CKD), in those with CKD-Mineral and Bone Disorder (CKD-MBD) and in those undergoing dialysis.

"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," the authors wrote.

The study was led by Steven T. Bird, PhD, PharmD, Office of Pharmacovigilance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland. It was published online in Annals of Internal Medicine.

The study population included only female Medicare beneficiaries, potentially affecting its applicability to men and non-Medicare populations. Researchers lacked access to clinical laboratory data for estimated glomerular filtration rates. This study did not account for cases of hypocalcemia treated in nonemergent care settings or undiagnosed instances among patients whose serum calcium levels were not regularly monitored.

This study received funding from the Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. One author declared employment with the Centers for Medicare & Medicaid Services, and another declared employment with the US Food and Drug Administration. Additional authors reported having ties with Acumen, LLC, a contractor on this study's interagency agreement.