A Pilot Study on the Immunopathogenesis of Bone Disease in Older HIV-infected Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Assess the associations between outcome (bone density) and predictors (markers of inflammation and immune activation) using continuous variables
研究概览
简要总结
This study will look to see if there are changes in the blood cells that are associated with bone disease and sort out effects that are due to the HIV virus itself, the medications and see if faster aging occurs in the cells of HIV infected persons. Bone disease will be measured by a special X-ray called a DEXA scan. A DEXA scan is used by doctors to see if someone has normal bone mass for their age or if there is thinning of the bones.
The purposes of this study are:
- to learn how common bone disease is in HIV infected patients over the age of 50 years that receive their care at the CORE Center
- to see what are the common causes of bone disease in older HIV infected persons
- to see if there are differences in blood cells and levels of cytokines in patients who do or do not have bone disease, as this may help researchers determine the cause of bone disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection documented by ELISA and confirmed by western blot
- •Treatment with antiretroviral drugs for at least 12 months
- •Age 50-70 years
- •CD4 count > 350 cells/mm3 for at least 6 months
- •HIV-RNA undetectable (< 75 copies/ml for at least 6 months)
排除标准
- •Known bone disease (primary or metastatic malignancy, osteomalacia)
- •Treatment for bone disease (bisphosphonates, calcitonin, strontium, sodium fluoride, synthetic PTH, or high-dose vitamin D [> 800 IU daily]).
结局指标
主要结局
Assess the associations between outcome (bone density) and predictors (markers of inflammation and immune activation) using continuous variables
时间窗: 6 months
次要结局
未报告次要终点
研究者
oluwatoyin M. Adeyemi
principal investigator
Ruth M. Rothstein CORE Center
