A RANDOMIZED DOUBLE-BLIND STUDY TO EVALUATE AMG 162 IN THE PREVENTION OF

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Postmenopausal osteoporosis is a systemic skeletal disease characterized by low bone mass with a subsequent increase in bone fragility and susceptibility to fracture. It affects an estimated 75 million people worldwide. Antiresorptive therapies decrease bone turnover, resulting in an improvement in bone mineral density (BMD). AMG 162 inhibits bone resorption. AMG 162 is a fully human monoclonal antibody to osteoprotegerin ligand, a major cytokine that regulates osteoclastogenesis. The primary objective of this study is to determine whether AMG 162 treatment can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia (lumbar spine bone mineral density (BMD) T-score between -1.0 and -2.5). The hypothesis is that AMG 162 compared with control (all subjects supplemented with calcium and vitamin D) will show a greater percent change in BMD at the lumbar spine in both early and late postmenopausal osteopenic women. This is a multi-center, randomized, double blind, parallel group, study in postmenopausal women with osteopenia (T-score between -1.0 and -2.5). The primary clinical hypotheses are that AMG 162 compared with control (all subjects supplemented with calcium and vitamin D) will show greater percent change in BMD at the lumbar spine in both early (? 5 years since menopause) and late (>5 years since menopause) postmenopausal osteopenic women. It is further hypothesized that both early and late osteopenic women receiving AMG 162 will show a greater percent change in total, cortical, and trabecular volumetric BMD as compared to those receiving control. A total of approximately 300 subjects will be enrolled into the study.