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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Bone Mineral Density of Children and Adolescents With Systemic Lupus Erythematosus

Brief 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 Summary:

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
Sponsor: University of California, San Francisco

Current Primary Outcome: Evaluate whether weak bones are associated with things like medications or amount of fat in muscle [ Time Frame: One year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, San Francisco

Dates:
Date Received: December 19, 2007
Date Started: September 2003
Date Completion: September 2015
Last Updated: October 25, 2014
Last Verified: October 2014