Study to Evaluate the Natural History of Osteoporosis in Children and Adolescents With Systemic Lupus Erythematosus
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lupus |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 7 - 22 |
| Updated: | 11/8/2018 |
| Start Date: | September 2003 |
| End Date: | September 2025 |
Bone Mineral Density of Children and Adolescents With Systemic Lupus Erythematosus
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.
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.
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.
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.
Inclusion criteria:
- Systemic Lupus Erythematosus 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 Systemic Lupus Erythematosus
- 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.
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