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

AMG 162 治疗骨矿物质密度低的绝经后妇女

• 批准号: 7379071
• 负责人: MUNRO PEACOCK
• 金额: $ 0.02万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379071
• 关键词: AMG; 162; TREATMENT; POSTMENOPAUSAL; WOMEN

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.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项2期随机、双盲、安慰剂对照、多中心、平行组、剂量范围的研究，对象为骨密度低的绝经后妇女。假设AMG 162皮下注射(SC)每隔3个月或6个月进行一次，持续两年将显著增加腰椎骨密度(&gt；3%)，耐受性良好，可以选择有效、安全和耐受性良好的剂量方案进行后续研究。大约320名受试者将被登记到8个队列中，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6 mg、14 mg或30 mg AMG 162，或每6个月60 mg、100 mg或210 mg AMG 162。一个队列将被随机接受每周70 mg的开放标签口服Fosamax，另一个队列将被随机接受每3个月服用SC的安慰剂。