Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children
Completed
- Conditions
- Systemic Lupus Erythematosus
- Registration Number
- NCT01330368
- Lead Sponsor
- Children's Hospital of Philadelphia
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Age and sex specific z-scores for lumbar spine (L2) volumetric bone mineral density (BMD) (trabecular and total) and vertebral volume. 2 years
- Secondary Outcome Measures
Name Time Method Mean lumbar spine stiffness and strength in children with SLE and healthy controls correlation between standard and low dose lumbar spine. 2 years
Trial Locations
- Locations (1)
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States