Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2017
First posted: Apr 6, 2011
Registry last updated: Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed