A recent study published in the Journal of the American Medical Association has found that denosumab, a drug used to treat osteoporosis, is linked to a higher risk of severe or very severe hypocalcemia in female patients aged 65 or older who are dependent on dialysis.
The research was led by Steven T. Bird, Ph.D., Pharm.D., from the U.S. Food and Drug Administration, and his team. They conducted a retrospective cohort study comparing the risk of severe hypocalcemia in patients treated with denosumab and those treated with oral bisphosphonates. Severe hypocalcemia was defined as total albumin-corrected serum calcium less than 7.5 mg/dL or a primary hospital or emergency department diagnosis of hypocalcemia. Very severe hypocalcemia was defined as serum calcium less than 6.5 mg/dL.
The study found that out of 1,523 patients treated with denosumab, 607 developed severe hypocalcemia. In contrast, only 23 out of 1,281 patients treated with oral bisphosphonates developed the condition. The 12-week weighted cumulative incidence of severe hypocalcemia was 41.1% for denosumab and 2.0% for oral bisphosphonates, giving a weighted risk ratio of 20.7. For very severe hypocalcemia, the 12-week weighted cumulative incidence was 10.9% for denosumab and 0.4% for oral bisphosphonates, giving a weighted risk ratio of 26.4.
The researchers concluded that due to the high risk associated with denosumab and the complexity of diagnosing the underlying bone pathophysiology in dialysis-dependent patients, denosumab should be administered with caution. They recommend careful patient selection and frequent monitoring to manage and treat severe hypocalcemia. This conclusion emphasizes the importance of personalized treatment plans in managing complex health conditions.