Back in April I reviewed the use of Aredia, Zometa, and denosumab for the prevention of skeletal-related events (SREs), in patients with cancer with bony metastases. SREs, defined as pain or fracture in a bone from cancer involvement, can result in the need for radiation, surgery, or other intervention, and consequently is damaging to the quality of life of patients with advanced cancer.
At that time, denosumab had been studied primarily in the treatment of osteoporosis, although a number of trials were ongoing in cancer patients. The only published large randomized trial in cancer patients at that time compared denosumab to placebo in women with surgically-resected breast cancer who were receiving endocrine therapy. Denosumab or placebo was administered every 6 months, with the outcomes of measuring an increase in bone density. Denosumab was shown to be better than placebo at increasing bone density. Measurement of SREs was not the goal of this trial.




