Study to Evaluate the Natural History of Osteoporosis in Children and Adolescents With Systemic Lupus Erythematosus (BMD)
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|ClinicalTrials.gov Identifier: NCT00582465|
Recruitment Status : Unknown
Verified October 2014 by University of California, San Francisco.
Recruitment status was: Active, not recruiting
First Posted : December 28, 2007
Last Update Posted : October 28, 2014
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.
|Condition or disease|
|Lupus Erythematosus, Systemic|
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.
|Study Type :||Observational|
|Estimated Enrollment :||425 participants|
|Official Title:||Bone Mineral Density of Children and Adolescents With Systemic Lupus Erythematosus|
|Study Start Date :||September 2003|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2015|
- Evaluate whether weak bones are associated with things like medications or amount of fat in muscle [ Time Frame: One year ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582465
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Emily von Scheven||University of California, San Francisco|