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

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。绝经后骨质疏松症是一种以骨量减少为特征的全身性骨骼疾病，随之而来的是骨脆性增加和骨折易感性增加。据估计，全球有7500万人受到影响。抗吸收治疗可降低骨转换，从而改善骨密度。AMG 162抑制骨吸收。AMG 162是一种全人抗骨保护素配体的单抗，骨保护素配体是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治疗是否可以预防患有骨量减少(腰椎骨密度(BMD)T评分在-1.0和-2.5之间)的绝经后早期和晚期妇女的腰椎骨丢失。假设是，与对照组(所有受试者都补充了钙和维生素D)相比，AMG 162在早期和晚期绝经后骨质疏松症女性的腰椎骨密度中显示出更大的百分比变化。这是一项多中心、随机、双盲、平行分组，研究对象为绝经后骨量减少(T评分在-1.0和-2.5之间)的妇女。主要的临床假设是，与对照组(所有受试者都补充钙和维生素D)相比，AMG 162在绝经后骨质疏松症早期(绝经后5年)和晚期(绝经5年后)腰椎骨密度变化百分比都更大。进一步的假设是，与接受对照组相比，接受AMG 162治疗的早期和晚期骨量减少的女性在总骨密度、皮质骨密度和骨小梁体积骨密度方面显示出更大的百分比变化。总共将有大约300名受试者参加这项研究。

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.