Hypocalcaemia in patients with metastatic bone disease treated with denosumab. Issue 13 (September 2015)

• Record Type: Journal Article
• Authors: Body, Jean-Jacques; Bone, Henry G.; de Boer, Richard H.; Stopeck, Alison; Van Poznak, Catherine; Damião, Ronaldo; Fizazi, Karim; Henry, David H.; Ibrahim, Toni; Lipton, Allan; Saad, Fred; Shore, Neal; Takano, Toshimi; Shaywitz, Adam J.; Wang, Huei; Bracco, Oswaldo L.; Braun, Ada; Kostenuik, Paul J.
• Is Part Of: European journal of cancer. Volume 51:Issue 13(2015:Sep.)
• Page Start: 1812
• Page End: 1821
• Publication Date: 2015-09
• Subjects: Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2015.05.016
• Languages: English
• ISSNs: 0959-8049

Abstract

<abstract xml:lang="en" abstract-type="author" id="ab005"> <title id="st005">Abstract</title> <sec> <title id="st010">Background</title> <p id="sp0005">This analysis was performed to further characterise treatment-emergent hypocalcaemia in patients with bone metastases receiving denosumab.</p> </sec> <sec> <title id="st015">Methods</title> <p id="sp0010">Laboratory abnormalities and adverse events of hypocalcaemia in patients with metastatic bone disease were analysed using data from three identically designed phase 3 trials of subcutaneous denosumab 120 mg (<italic>n</italic> = 2841) versus intravenous zoledronic acid 4 mg (<italic>n</italic> = 2836).</p> </sec> <sec> <title id="st020">Results</title> <p id="sp0015">The overall incidence of laboratory events of hypocalcaemia grade ⩾2 was higher with denosumab (12.4%) than with zoledronic acid (5.3%). Hypocalcaemia events were primarily grade 2 in severity and usually occurred within the first 6 months of treatment. Patients who reported taking calcium and/or vitamin D supplements had a lower incidence of hypocalcaemia. Prostate cancer or small-cell lung cancer, reduced creatinine clearance and higher baseline bone turnover markers of urinary N-telopeptide of type I collagen (uNTx; >50 versus ⩽50 nmol/mmol) and bone-specific alkaline phosphatase (BSAP; >20.77 μg/L [median] versus ⩽20.77 μg/L) values were important risk factors for developing hypocalcaemia. The risk associated with increased baseline BSAP levels was greater among patients who had >2 bone metastases at baseline versus those with ⩽2 bone metastases at baseline.</p> </sec> <sec> <title id="st025">Conclusion</title> <p id="sp0020">Hypocalcaemia was more frequent with denosumab versus zoledronic acid, consistent with denosumab's greater antiresorptive effect. Low serum calcium levels and potential vitamin D deficiency should be corrected before initiating treatment with a potent osteoclast inhibitor, and corrected serum calcium levels should be monitored during treatment. Adequate calcium and vitamin D intake appears to substantially reduce the risk of hypocalcaemia.</p> </sec> </abstract>