Original Article Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis Steven R. Cummings, M.D., Javier San Martin, M.D., Michael R. McClung, M.D., Ethel S. Siris, M.D., Richard Eastell, M.D., Ian R. Reid, M.D., Pierre Delmas, M.D., Ph.D., Holly B. Zoog, Ph.D., Matt Austin, M.S., Andrea Wang, M.A., Stepan Kutilek, M.D., Silvano Adami, M.D., Ph.D., Jose Zanchetta, M.D., Cesar Libanati, M.D., Suresh Siddhanti, Ph.D., Claus Christiansen, M.D., for the FREEDOM Trial N Engl J Med Volume 361(8): August 20, 2009
Study Overview In this trial, women between the ages of 60 and 90 with low bone mineral density received twice-yearly subcutaneous injections of denosumab, a fully human monoclonal antibody against the receptor activator of nuclear factor- B ligand, which inhibits the development and activity of osteoclasts, or placebo Denosumab was associated with a reduced risk of vertebral, nonvertebral, and hip fractures
Baseline Characteristics of the Subjects Cummings SR et al. N Engl J Med 2009;361:
Effect of Denosumab on the Risk of Fracture at 36 Months Cummings SR et al. N Engl J Med 2009;361:
Incidence of New Vertebral, Nonvertebral, and Hip Fractures Cummings SR et al. N Engl J Med 2009;361:
Percent Changes in Bone Mineral Density and Biochemical Markers of Bone Turnover Cummings SR et al. N Engl J Med 2009;361:
Adverse Events Cummings SR et al. N Engl J Med 2009;361:
Conclusion Denosumab given subcutaneously twice yearly for 36 months was associated with a reduction in the risk of vertebral, nonvertebral, and hip fractures in women with osteoporosis