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

评估 AMG 162 预防疾病的随机双盲研究

• 批准号: 7379139
• 负责人: MUNRO PEACOCK
• 金额: $ 0.14万
• 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/7379139
• 关键词: RANDOMIZED; DOUBLE; BLIND; STUDY; EVALUATE

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。绝经后骨质疏松症是一种全身性骨骼疾病，其特征是骨量低，随后骨脆性增加和骨折易感性增加。据估计，它影响着全世界 7500 万人。抗骨吸收疗法可减少骨转换，从而改善骨矿物质密度（BMD）。 AMG 162 抑制骨吸收。 AMG 162 是一种针对骨保护素配体的全人单克隆抗体，骨保护素配体是调节破骨细胞生成的主要细胞因子。本研究的主要目的是确定 AMG 162 治疗是否可以预防早期和晚期绝经后骨质减少女性（腰椎骨矿物质密度 (BMD) T 评分在 -1.0 和 -2.5 之间）的腰椎骨质流失。假设与对照（所有补充钙和维生素 D 的受试者）相比，AMG 162 在早期和晚期绝经后骨质疏松女性中，腰椎 BMD 的变化百分比更大。 这是一项多中心、随机、双盲、平行组研究，对象是患有骨质减少的绝经后女性（T 值在 -1.0 和 -2.5 之间）。主要的临床假设是，与对照（所有补充钙和维生素 D 的受试者）相比，AMG 162 在早期（绝经后 5 年以上）和晚期（绝经后 > 5 年）腰椎 BMD 的百分比变化更大）绝经后骨质疏松的女性。进一步假设，与接受对照的女性相比，接受 AMG 162 的早期和晚期骨质疏松女性的总骨密度、皮质骨密度和小梁骨体积 BMD 的变化百分比更大。总共约 300 名受试者将被纳入该研究。