NCT00582465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 1999

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

5 years

First QC Date

December 19, 2007

Last Update Submit

March 30, 2020

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

  • Evaluate whether weak bones are associated with things like medications or amount of fat in muscle

    Bone density measurements by DXA

    One year

Secondary Outcomes (1)

  • Evaluate whether weak bones are associated with things like medications or amount of fat in muscle

    one year

Study Arms (1)

Observation

Lupus

Eligibility Criteria

Age7 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents with SLE

You may qualify if:

  • Systemic Lupus Erythematosus subjects 4/11 of the American College of Rheumatology criteria for SLE (23), age less than 22 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Emily von Scheven

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 28, 2007

Study Start

July 21, 1999

Primary Completion

July 9, 2004

Study Completion

July 9, 2004

Last Updated

April 1, 2020

Record last verified: 2020-03

Locations

US(1)