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。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。绝经后骨质疏松症是一种全身性骨骼疾病，其特征是骨骼低，随后骨骼脆弱性和骨折易感性增加。它影响了全球估计有7500万人。抗吸收性疗法会减少骨转换，从而改善骨矿物质密度（BMD）。 AMG 162抑制骨吸收。 AMG 162是一种完全人类的单克隆抗体，它是骨蛋白蛋白蛋白配体，这是一种调节破骨细胞生成的主要细胞因子。这项研究的主要目的是确定AMG 162治疗是否可以预防骨质减少术的早期和晚期妇女（腰椎骨骨矿物质密度（BMD）T评分-1.0和-2.5）的腰椎骨质丧失。假设是，与对照（所有补充钙和维生素D的受试者）相比，AMG 162在绝经后早期和晚期的腰椎脊柱上的BMD变化较大。 这是一个多中心，随机，双盲，平行组，对绝经后女性骨质减少症（-1.0和-2.5之间的T得分）进行研究。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（自更年期以来5年）和绝经后骨后骨骨质妇女的早期（自更年期以来> 5年（> 5年以来），BMD的百分比变化较大。进一步的假设是，与接受对照的人相比，接受AMG 162的早期和晚期骨质减少妇女的总数变化更高，皮质和小梁体积BMD的变化更大。该研究总共将招募约300名受试者。