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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项2期、随机、双盲、安慰剂对照、多中心、平行组、剂量范围研究，研究对象为低骨密度（BMD）绝经后妇女。假设每3个月或6个月皮下注射AMG 162 (SC) 2年可显著增加腰椎骨密度（bb3%），且耐受性良好，可为后续研究选择有效、安全、耐受性良好的剂量方案。大约320名受试者将被纳入8个队列，每个队列40名受试者。三个队列将接受以下剂量和频率的双盲SC剂量：每3个月6mg、14mg或30mg AMG 162，或每6个月60mg、100mg或210mg AMG 162。一个队列将随机接受开放标签口服福善美70mg每周，一个队列将随机接受安慰剂，每3个月给药一次SC。

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.