This trial is active, not recruiting.

Condition systemic lupus erythematosus
Sponsor Children's Hospital of Philadelphia
Start date October 2010
End date July 2013
Trial size 32 participants
Trial identifier NCT01330368, 10-007747


The purpose of this study is to compare healthy children to children who have systemic lupus erythematosus (SLE). SLE is a childhood disease that has high risk for low bone mass and vertebral compression fractures.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional

Primary Outcomes

Age and sex specific z-scores for lumbar spine (L2) volumetric bone mineral density (BMD) (trabecular and total) and vertebral volume.
time frame: 2 years

Secondary Outcomes

Mean lumbar spine stiffness and strength in children with SLE and healthy controls correlation between standard and low dose lumbar spine.
time frame: 2 years

Eligibility Criteria

Male or female participants from 5 years up to 21 years old.

Inclusion Criteria: - For SLE subjects: Subjects age 5-21 drawn from rheumatology clinic at Children's Hospital of Philadelphia diagnosed with SLE for at least 1 month. Also subjects with no known vertebral compression fracture of L2. - For Control subjects: Subjects age 5-21. Controls will be a 50% male/female. Exclusion Criteria: - For SLE subjects: Subjects with SLE will be excluded if they have conditions or drug exposure unrelated to SLE and known to impact growth or bone health. - For Control subjects: Chronic disease or syndrome known to affect growth or bone health, prematurity (<37 weeks gestation), or use of any medication known to affect growth.

Additional Information

Official title Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children
Principal investigator Jon Burnham, MD, MSCE
Description The purpose of this research study is to measure bone mass in children with SLE using different measurement techniques. Children with chronic illnesses are at risk of bone fragility. This is important because bone fragility can result in childhood fractures especially children with SLE. Therefore better diagnosis technique can lead to better management of bone health.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.