Background Denosumab is a human monoclonal antibody used to prevent skeletal-related events (SREs) in patients with bone metastases from solid tumours. Although antiresorptive treatment reduces the risk of SREs, it also reduces the release of calcium (Ca) from bone into the bloodstream. In September 2014, the Spanish Agency for Medicines and Health Products issued an alert for the risk of severe hypocalcaemia in patients receiving denosumab, recommending that Ca levels be monitored and adequate Ca and vitamin D supplementation be given.
Purpose To determine the prevalence of hypocalcaemia induced by denosumab.
Material and methods A retrospective review of patients undergoing treatment with denosumab from April 2013 to October 2014 in a general hospital. Demographic and clinical data were obtained from Pharmacy Department records, patient medical histories and laboratory software.
Results A total of 28 patients treated with denosumab were included in the study (53.6% male, mean age 62.6 ± 14.2). Hypocalcaemia was observed in 10 patients (35.7%): 3 grade I, 5 grade II, 1 grade III and 1 grade IV (Common Terminology Criteria for Adverse Events, v4.0). 3 patients who developed hypocalcaemia had impaired renal function at baseline (GFR < 35 ml/min). 16 of all patients (57.1%) received Ca and vitamin D supplementation. Hypocalcaemia was more common in patients who did not receive Ca and vitamin D vs. those who did (6 vs. 4 patients). Only 2 patients developed grade III or IV hypocalcaemia, they both did not take Ca and vit D supplements.
Conclusion Hypocalcaemia is a common side effect of denosumab despite adequate calcium and vitamin D supplementation. Despite the small sample size, we recorded less hypocalcaemia in patients taking Ca and vitamin D. Ca levels should be closely monitored during denosumab treatment.
References and/or acknowledgements No conflict of interest.
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