Recently, the monoclonal antibody denosumab has been registered as a new first-in-class treatment option for the prevention of skeletal-related events (SREs) in patients with bone metastases from a solid tumour, for the treatment of treatment-induced bone loss (TIBL) in prostate cancer, and the treatment of post-menopausal osteoporosis. The present article reviews the mechanism of action of denosumab and the research leading to the registered indications in cancer patients. (BELG J MED ONCOL 2012;6:118–123)