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

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ClinicalTrials.gov Identifier: NCT00582465
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.


Condition or disease
Lupus Erythematosus, Systemic

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.

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Study Type : Observational
Actual Enrollment : 243 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Mineral Density of Children and Adolescents With Systemic Lupus Erythematosus
Actual Study Start Date : July 21, 1999
Actual Primary Completion Date : July 9, 2004
Actual Study Completion Date : July 9, 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density Lupus

Group/Cohort
Observation
Lupus



Primary Outcome Measures :
  1. Evaluate whether weak bones are associated with things like medications or amount of fat in muscle [ Time Frame: One year ]
    Bone density measurements by DXA


Secondary Outcome Measures :
  1. Evaluate whether weak bones are associated with things like medications or amount of fat in muscle [ Time Frame: one year ]
    Bone density measurements by computed tomography


Biospecimen Retention:   Samples With DNA
Serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents with SLE
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582465


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Emily von Scheven University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00582465    
Other Study ID Numbers: H8994-14731
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases