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

Lupus Erythematosus, Systemic Clinical Trial

— BMD  

Official title:

Bone Mineral Density of Children and Adolescents With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582465
• Other study ID #: H8994-14731
• Status: Completed
• Start date: July 21, 1999
• Est. completion date: July 9, 2004

Study information

• Verified date: March 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: July 9, 2004
• Est. primary completion date: July 9, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate whether weak bones are associated with things like medications or amount of fat in muscle	Bone density measurements by DXA	One year
Secondary	Evaluate whether weak bones are associated with things like medications or amount of fat in muscle	Bone density measurements by computed tomography	one year