Denosumab--an emerging treatment for postmenopausal osteoporosis.

IMPORTANCE OF THE FIELD: Osteoporosis is a common skeletal disease that is associated with an imbalance in bone remodeling. Denosumab is an investigational fully human monoclonal antibody to receptor activator of NF-kappaB ligand (RANKL), a cytokine member of the TNF family that is the principal mediator of osteoclastic bone resorption. AREAS COVERED IN THIS REVIEW: The efficacy and safety of denosumab in the management of postmenopausal osteoporosis is evaluated by reviewing the published literature and presentations at scientific meetings through 2009. WHAT THE READER WILL GAIN: This review focuses on the data on fracture risk reduction and safety endpoints of denosumab in the treatment of postmenopausal osteoporosis. TAKE HOME MESSAGE: In postmenopausal women with osteoporosis, denosumab (60 mg by subcutaneous injection every 6 months) increased bone mineral density, reduced bone turnover markers, and reduced the risk of vertebral, hip and non-vertebral fractures. Denosumab was well tolerated with a safety profile generally similar to placebo. It is a promising emerging drug for the prevention and treatment of postmenopausal osteoporosis.