Hypocalcaemia in patients with metastatic bone disease (MBD) receiving denosumab — ASN Events
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Hypocalcaemia in patients with metastatic bone disease (MBD) receiving denosumab (#195)

Richard H De Boer 1 , Jean-Jacques Body 2 , Allan Lipton 3 , Alison Stopeck 4 , Karim Fizazi 5 , Henry G Bone 6 , Fred Saad 7 , Catherine Van Poznak 8 , Neal Shore 9 , Toni Ibrahim 10 , Toshimi Takano 11 , Ronaldo Damião 12 , Huei Wang 13 , Paul J Kostenuik 13 , Adam Shaywitz 13 , Oswaldo L Bracco 13 , Ada Braun 13
  1. Royal Melbourne Hospital, Melbourne, Victoria, Australia
  2. CHU Brugmann, Université Libre de Bruxelles , Brussels, Belgium
  3. Pennsylvania State University, Milton S Hershey Medical Center, Hershey, Pennsylvania , USA
  4. University of Arizona Cancer Center, Tuscon, Arizona, USA
  5. Institut Gustave Roussy, University of Paris Sud, Villejuif, France
  6. Michigan Bone and Mineral Clinic, Detroit, Michigan, USA
  7. University of Montreal Hospital Center, Montreal, Quebec, Canada
  8. University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, USA
  9. Carolina Urologic Research Center, Myrtle Beach, South Carolina, USA
  10. IRCCS- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy
  11. Toranomon Hospital, Tokyo, Japan
  12. Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil
  13. Amgen Inc, Thousand Oaks, California, USA

Aims: Hypocalcaemia is a known risk with antiresorptive therapy for skeletal complications of malignancy. Results from a combined analysis of hypocalcaemic events from three phase 3 trials of denosumab and zoledronic acid (ZA) in patients with MBD and data from post-marketing adverse event reports (AER) are presented.
Methods: Patients with solid tumours or multiple myeloma were randomised to denosumab 120mg SC Q4W or ZA 4mg IV (adjusted for renal function) Q4W. Daily calcium (≥500mg) and vitamin D (≥400IU) were recommended. Albumin-corrected serum calcium was measured Q4W by central lab. Hypocalcaemic events were collected as decreases in serum calcium and investigator-reported AEs. Post-marketing AER of hypocalcaemia included in the Amgen Global Safety database (AGS) were reviewed.
Results: 2841 and 2836 patients received denosumab and ZA, respectively. Median calcium levels for both treatment groups were similar over time. Among denosumab patients, hypocalcaemia was most common within 6 months of starting treatment, and more common in patients not taking calcium and vitamin D (15.8%) vs those who did (8.7%). Grade 3/4 (<1.75mmol/L) decreases in serum calcium were reported in 3.1% and 1.3% of denosumab and ZA patients, respectively. No fatal hypocalcaemia cases were reported in the trials. From May–Nov 2012, 37 cases of severe symptomatic hypocalcaemia were reported and recorded in the AGS; fatal outcomes were reported for 3 other patients with advanced cancers and various comorbidities.
Conclusions: Hypocalcaemia is a risk associated with antiresorptive therapy when treating bone metastases and myeloma. It occurred less often in patients taking calcium and vitamin D. Serum calcium and vitamin D levels should be checked and hypocalcaemia corrected prior to starting denosumab. Calcium levels should be monitored and calcium and vitamin D taken while receiving denosumab.

Body JJ et al. Hypocalcaemia in patients with metastatic bone disease receiving denosumab. J Clin Oncol 31,2013(suppl;abstr 9628). Reused with permission.©2012 American Society of Clinical Oncology. All rights reserved.