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资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。绝经后骨质疏松症是一种全身性骨骼疾病，其特征是骨量减少，随后骨脆性增加，易发生骨折。据估计，全世界有7500万人受到影响。抗骨吸收治疗可降低骨转换，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（一种调节破骨细胞生成的主要细胞因子）的全人源单克隆抗体。本研究的主要目的是确定AMG 162治疗是否可预防绝经早期和晚期骨质减少女性（腰椎骨矿物质密度（BMD）T评分为-1.0至-2.5）的腰椎骨丢失。假设AMG 162与对照组（补充钙和维生素D的所有受试者）相比，在绝经后早期和晚期骨质疏松女性中腰椎BMD的百分比变化更大。 这是一项在绝经后骨质减少女性（T评分在-1.0和-2.5之间）中进行的多中心、随机、双盲、平行组研究。主要临床假设是AMG 162与对照组（所有补充钙和维生素D的受试者）相比，在两个早期（？）绝经后5年）和晚期（绝经后>5年）绝经后骨质疏松妇女。进一步假设接受AMG 162的早期和晚期骨质减少女性与接受对照的女性相比，在总骨密度、皮质骨密度和骨小梁体积骨密度方面的百分比变化更大。总共约300例受试者将入组本研究。