Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Lupus

Primary Outcomes

Measure
Evaluate whether weak bones are associated with things like medications or amount of fat in muscle
time frame: One year

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by University of California, San Francisco.