Study to Evaluate the Natural History of Osteoporosis in Children and Adolescents With Systemic Lupus Erythematosus
This trial is active, not recruiting.
|Condition||lupus erythematosus, systemic|
|Sponsor||University of California, San Francisco|
|Start date||September 2003|
|End date||September 2015|
|Trial size||425 participants|
|Trial identifier||NCT00582465, H8994-14731|
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.
Evaluate whether weak bones are associated with things like medications or amount of fat in muscle
time frame: One year
Male or female participants from 7 years up to 22 years old.
Inclusion criteria: - SlE subjects 4/11 of the American College of Rheumatology criteria for SLE (23), age less than 22 years. Exclusion Criteria: - Neonatal SLE or drug-induced SLE - 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.
|Official title||Bone Mineral Density of Children and Adolescents With Systemic Lupus Erythematosus|
|Principal investigator||Emily von Scheven|
|Description||This is a longitudinal cohort study to evaluate the natural history of osteoporosis in children and adolescents with SLE. The specific Aims are: - To compare the BMD of children and adolescents with SLE 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 SLE? Is the BMD of children with SLE 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 SLE 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 SLE. - To characterize the determinants of BMD and corresponding markers of bone metabolism in a longitudinal cohort of pediatric SLE subjects. - To bank SLE 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 SLE utilizing whole body DXA and to determine the contribution of body composition abnormalities to BMD. Research Design and Method: This study includes a baseline cross-sectional component comparing SLE subjects to normal healthy controls followed by a longitudinal follow up study of SLE subjects. SLE subjects and controls will be evaluated in a single-day visit to the UCSF PCRC for clinical assessment and phlebotomy followed by a radiologic evaluation at the Department of Radiology.|
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