| Summary: | Osteoporosis is a skeletal disorder characterized by compromised bone strength predisposing patients to an increased risk of fracture. In men, coexisting conditions and risk factors often combine with age-related, slowly proceeding bone loss to result in osteoporosis and fragility fractures. Osteoporotic fractures are a significant health care concern with devastating impacts on patients, often leading to an increased risk of subsequent fracture, hospitalization, decreased quality of life, premature mortality, and increased burden on the health care system. For men requiring treatment of osteoporosis, the Osteoporosis Canada 2010 guidelines recommend the oral bisphosphonates alendronate and risedronate, as well as the parenteral bisphosphonate zoledronic acid, as first-line treatment options. Denosumab is a human monoclonal antibody binding to human receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab has a Health Canada indication as treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or in patients who have failed or are intolerant to other available osteoporosis therapy. The drug plans that participate in the CADTH Common Drug Review (CDR) process have requested that denosumab be evaluated for reimbursement for treating osteoporosis in men according to the Health Canada indication. The objective of this report was to perform a systematic review of the beneficial and harmful effects of denosumab as a treatment to increase bone mass in men with osteoporosis at high risk for fracture, or who have failed or are intolerant to other available osteoporosis therapy
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