Denosumab for the Treatment of Postmenopausal Osteoporosis

Denosumab is an investigational fully human monoclonal antibody to RANKL, a cytokine member of the tumor necrosis factor family that is the principal mediator of osteoclastic bone resorption. RANKL stimulates the differentiation, activity and survival of osteoclasts, and is implicated in the pathogenesis of postmenopausal osteoporosis and other skeletal disorders associated with high rates of bone remodeling. By inhibiting the action of RANKL, denosumab reduces the differentiation, activation and survival of osteoclasts and slows the rate of bone resorption. Postmenopausal women with low bone mineral density treated with denosumab have an increase in bone mineral density and a reduction of bone turnover markers that is rapid, sustained and reversible. In postmenopausal women with osteoporosis, denosumab reduces the risk of vertebral, hip and nonvertebral fractures. Denosumab is well tolerated with a favorable safety profile.