Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)
In a group of HIV-positive patients under observation since their first exposure to ART or monitored off of ART, BMD changes over one year will be determined. For each subject, the investigators will also determine associations between changes in BMD and 1) ART initiation, 2) cumulative viremia (measured by copy-years viremia), and 3) inflammation (evaluated through the measurement of interleukin-6 {IL-6}, tumor necrosis factor alpha {TNF-a}, high-sensitivity c-reactive protein {hsCRP}).
Hypotheses: BMD will decrease less in persons initiated on ART than those monitored off of ART, after excluding those subjects treated with tenofovir.
BMD will decrease most significantly in HIV-positive subjects with the highest levels of cumulative viremia.
HIV-positive persons with highest cumulative viremia will have the highest levels of inflammation, as measured by pro-inflammatory cytokines.
Additionally, the investigators will evaluate fracture incidence in a 5% National Medicare sample and fracture association with the use of varying ART medications among dual-eligible persons in Medicare and Medicaid datasets.
Hypotheses: Fracture incidence will be greater in HIV-positive subjects compared to HIV-negative subjects.Fracture incidence will be greatest in subjects with the shortest duration of ART exposure.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国、35233
- UAB
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- treatment naïve patients seen in the 1917 Clinic between January 1, 2000 and May 1, 2010
- currently under care at the time of the initiation of the study (>1 clinic visit in the past 12 months)
Exclusion Criteria:
- history of chronic renal failure (estimated GFR <30ml/min)
- known diagnosis of a metabolic bone disease (i.e. osteoporosis, primary hyperparathyroidism, Paget Disease, Osteogenesis Imperfecta)
- multiple myeloma, cancer, untreated thyroid disease, or inflammatory bowel disease, or persons currently treated with or plans to begin an osteoporosis-specific medication (including estrogen)
- treatment with oral glucocorticoids and anticonvulsants
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:横截面
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Bone Mineral Density
大体时间:1 year
|
Change in BMD after 1 year
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1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Fracture in HIV
大体时间:10years
|
Fracture incidence in HIV+ vs. HIV- in Medicare sample
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10years
|
合作者和调查者
调查人员
- 首席研究员:Amy H. Warriner, MD、University of Alabama at Birmingham
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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