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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00582465
First received: December 19, 2007
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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
Lupus Erythematosus, Systemic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Mineral Density of Children and Adolescents With Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Evaluate whether weak bones are associated with things like medications or amount of fat in muscle [ Time Frame: One year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Estimated Enrollment: 425
Study Start Date: September 2003
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
Lupus

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.

  Eligibility

Ages Eligible for Study:   7 Years to 22 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00582465     History of Changes
Other Study ID Numbers: H8994-14731
Study First Received: December 19, 2007
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014