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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01330368
Recruitment Status : Completed
First Posted : April 6, 2011
Last Update Posted : October 3, 2017
Information provided by (Responsible Party):
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.

Condition or disease
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
Actual Enrollment : 32 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children
Study Start Date : October 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus Osteoporosis

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA

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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01330368

United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Principal Investigator: Jon Burnham, MD, MSCE Children's Hospital of Philadelphia

Responsible Party: Children's Hospital of Philadelphia Identifier: NCT01330368     History of Changes
Other Study ID Numbers: 10-007747
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017

Keywords provided by Children's Hospital of Philadelphia:
Systemic Lupus Erythematosus
children with SLE

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases