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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus

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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

200 control patients (124 controls participated in unique protocol ID: 2007-10-5528 data will be used for this study, we will be trying to recruit about 76 control patients for this study) and 30 study patients with SLE

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Mean lumbar spine stiffness and strength in children with SLE and healthy controls correlation between standard and low dose lumbar spine.	2 years

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Jon Burnham, MD, MSCE, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (Estimate): April 6, 2011

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: September 29, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Lupus; SLE; Systemic Lupus Erythematosus; children with SLE
• Additional Relevant MeSH Terms: Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Bone Diseases, Metabolic; Lupus Erythematosus, Systemic; Osteoporosis
• Other Study ID Numbers: 10-007747