In men with bone metastasis from castration-resistant prostate cancer (CRPC), a monthly subcutaneous injection with denosumab, 120 mg, is superior to Zometa, a multinational group of researchers reported at the American Society of Clinical Oncology annual meeting.
The current standard of care is for men with bone metastasis from castration-resistant prostate cancer (CRPC) is to receive a monthly intravenous zoledronic acid (Zometa), 4 mg, for preventing and delaying multiple skeletal-related events (SREs). A phase III study, which enrolled 1,901 men, studied the difference in the prevention of SREs between Zometa and denosumab, recently approved by the FDA for treating postmenopausal osteoporosis, but nor approved for men who are suffering with CRPC . The trial randomized (1:1), was double blind, and of double-dummy design.
Prior to randomization, the men were stratified by serum PSA, previous or ongoing chemotherapy, and previous history of SRE. All of the subject men also received calcium and vitamin D supplementation.
During the study, more than 20% of zoledronic aci