Bone Mineral Density of Children and Adolescents With Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Evaluate whether weak bones are associated with things like medications or amount of fat in muscle
研究概览
简要总结
This is a study to determine if people with Lupus have weak bones.
Test which is a better method for detecting bone changes:
- Dual energy X-ray absorptiometry (DXA)
- Single energy quantitative computed tomography (SEQCT)
Evaluate whether weak bones are associated with things like medications or amount of fat and muscle.
详细描述
This is a longitudinal cohort study to evaluate the natural history of osteoporosis in children and adolescents with Systemic Lupus Erythematosus.
The specific Aims are:
- To compare the BMD of children and adolescents with Systemic Lupus Erythematosus to healthy controls utilizing Dual energy X-ray absorptiometry (DXA) and Single energy quantitative computed tomography (SEQCT). The following questions will be addressed at baseline:
What is the variation of BMD seen among subjects with Systemic Lupus Erythematosus? Is the BMD of children with Systemic Lupus Erythematosus diminished relative to healthy controls? If BMD is diminished, what is the severity of the reduction?
- To characterize the annual change in BMD for children and adolescents with Systemic Lupus Erythematosus over a five year period in a longitudinal cohort study utilizing arial and volumetric densitometry methods of both trabecular- and cortical-rich regions of bone.
- To compare the use of DXA and SEQCT for measuring BMD in children and adolescents with Systemic Lupus Erythematosus.
- To characterize the determinants of BMD and corresponding markers of bone metabolism in a longitudinal cohort of pediatric Systemic Lupus Erythematosus subjects.
- To bank Systemic Lupus Erythematosus subject blood and urine specimens for future analysis. Future analysis will focus on newly developed bone metabolism markers, as this is a currently evolving area.
- To evaluate body composition in Systemic Lupus Erythematosus utilizing whole body DXA and to determine the contribution of body composition abnormalities to BMD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Neonatal SLE or drug-induced Systemic Lupus Erythematosus
- •Subjects who are pregnant, and subjects weighing over 300 pounds, as the densitometry techniques are not reliable above this weight.
- •Subjects receiving calcium or vitamin D supplementation will not be excluded but this information will be recorded and evaluated further in the dietary/nutritional assessment.
结局指标
主要结局
Evaluate whether weak bones are associated with things like medications or amount of fat in muscle
时间窗: One year
Bone density measurements by DXA
次要结局
- Evaluate whether weak bones are associated with things like medications or amount of fat in muscle(one year)