Study to Evaluate the Natural History of Osteoporosis in Children and Adolescents With Systemic Lupus Erythematosus (BMD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00582465|
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : April 1, 2020
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 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.
Research Design and Method: This study includes a baseline cross-sectional component comparing Systemic Lupus Erythematosus subjects to normal healthy controls followed by a longitudinal follow up study of Systemic Lupus Erythematosus subjects. Systemic Lupus Erythematosus subjects and controls will be evaluated in a single-day visit to the University of California, San Francisco Pediatric Clinical Research Center for clinical assessment and phlebotomy followed by a radiologic evaluation at the Department of Radiology.
|Study Type :||Observational|
|Actual Enrollment :||243 participants|
|Official Title:||Bone Mineral Density of Children and Adolescents With Systemic Lupus Erythematosus|
|Actual Study Start Date :||July 21, 1999|
|Actual Primary Completion Date :||July 9, 2004|
|Actual Study Completion Date :||July 9, 2004|
- Evaluate whether weak bones are associated with things like medications or amount of fat in muscle [ Time Frame: One year ]Bone density measurements by DXA
- Evaluate whether weak bones are associated with things like medications or amount of fat in muscle [ Time Frame: one year ]Bone density measurements by computed tomography
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|