[A new treatment for osteoporosis using fully human monoclonal antibody to RANKL, AMG 162]

Abstract

RANKL is an essential factor for osteoclastogenesis. Amgen research group has developed AMG 162, a fully human monoclonal antibody to RANKL. The bone antiresorptive activity and safety of AMG 162 were evaluated in 49 healthy postmenopausal women (Phase I study). The effect of increasing amounts of AMG 162 on bone mineral density (BMD) was studied in 411 postmenopausal women with low BMD (Phase II study). A single subcutaneous dose of AMG 162 (1 mg/kg or 60 mg) suppressed bone resorption for more than 6 month without critical side effects (Phase I study), and increased BMD within 1 month in postmenopausal women (Phase II study).