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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330368
• Other study ID #: 10-007747
• Status: Completed
• Phase: N/A
• First received: December 14, 2010
• Last updated: September 29, 2017
• Start date: October 2010
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2017
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Osteoporosis
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age and sex specific z-scores for lumbar spine (L2) volumetric bone mineral density (BMD) (trabecular and total) and vertebral volume.		2 years
Secondary	Mean lumbar spine stiffness and strength in children with SLE and healthy controls correlation between standard and low dose lumbar spine.		2 years