NCT00582465

Study to Evaluate the Natural History of Osteoporosis in Children and Adolescents With Systemic Lupus Erythematosus

Bone Mineral Density of Children and Adolescents With Systemic Lupus Erythematosus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 243 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 7 Years – 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lupus Erythematosus, Systemic

Timeline

• Start date: 1999-07-21
• Primary completion: 2004-07-09
• Completion: 2004-07-09
• First posted: 2007-12-28
• Last updated: 2020-04-01

Locations

1 site across 1 country: United States