Effects of denosumab on bone mineral density and bone turnover in postmenopausal women.

Context: Denosumab is an investigational fully human monoclonal antibody against receptor activator of nuclear factor-κB ligand, a mediator of osteoclastogenesis and osteoclast survival. Objective: This study evaluated the ability of denosumab to increase bone mineral density (BMD) and decrease bone turnover markers (BTMs) in early and later postmenopausal women with low BMD. Design and Setting: This 2-yr randomized, double-blind, placebo-controlled study was conducted in North America. Participants: Subjects included 332 postmenopausal women with lumbar spine BMD T-scores between −1.0 and −2.5. Interventions: Subjects were randomly assigned to receive denosumab sc, 60 mg every 6 months, or placebo. Randomization was stratified by time since onset of menopause (≤5 yr or > 5 yr). Main Outcome Measures: The primary end point was the percent change in lumbar spine BMD by dual-energy x-ray absorptiometry at 24 months. Additional end points were percent change in volumetric BMD of the distal radius by quantita...