[A new treatment for osteoporosis using fully human monoclonal antibody to RANKL, AMG 162].
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).
Takahashi
Naoyuki
N
Department of Hard Tissue Research, Graduate School of Oral Science Course, Matsumoto Dental University, Japan.
Ozawa
Hidehiro
H
D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D015519:Bone Density; D001862:Bone Resorption / Q000188:drug therapy; D002352:Carrier Proteins / Q000737:chemistry / Q000276:immunology* / Q000502:physiology; D002454:Cell Differentiation / Q000235:genetics; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D000069448:Denosumab; D005260:Female; D006801:Humans; D008562:Membrane Glycoproteins / Q000737:chemistry / Q000276:immunology* / Q000502:physiology; D010010:Osteoclasts / Q000166:cytology; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D053245:RANK Ligand; D053246:Receptor Activator of Nuclear Factor-kappa B
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D002352:Carrier Proteins; D008562:Membrane Glycoproteins; D053245:RANK Ligand; D053246:Receptor Activator of Nuclear Factor-kappa B; C505686:TNFRSF11A protein, human; C505688:TNFSF11 protein, human; D000069448:Denosumab