AMG 162 IN THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH LOW BONE MINERAL DENSITY

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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. This is a phase 2, randomized, double-blind, placebo-controlled, multi-center, parallel group, dose ranging study in postmenopausal women with low bone mineral density (BMD). The hypothesis is that AMG 162 subcutaneous injections (SC) administered every 3 or 6 months for 2 years will significantly increase lumbar spine BMD (> 3%), will be well tolerated and that an effective, safe, and well-tolerated dose regimen can be selected for subsequent studies. Approximately 320 subjects will be enrolled into 8 cohorts of 40 subjects per cohort. Three cohorts will receive double-blind SC doses at the following doses and frequencies: 6mg, 14mg, or 30mg AMG 162 every 3 months, or 60mg, 100mg, or 210 mg AMG 162 every 6 months. One cohort will be randomized to receive open-label oral Fosamax 70mg weekly and one cohort will be randomized to receive placebo, administered SC every 3 months.