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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 : Unknown
Verified October 2014 by University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : December 28, 2007
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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 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.


Study Design

Study Type : Observational
Estimated Enrollment : 425 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Mineral Density of Children and Adolescents With Systemic Lupus Erythematosus
Study Start Date : September 2003
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Observation
Lupus


Outcome Measures

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

Biospecimen Retention:   Samples With DNA
Serum

Eligibility Criteria

Information from the National Library of Medicine

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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:

  • 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.
Contacts and Locations

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
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Emily von Scheven University of California, San Francisco
More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00582465     History of Changes
Other Study ID Numbers: H8994-14731
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases