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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01330368
First Posted: April 6, 2011
Last Update Posted: October 3, 2017
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.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
December 14, 2010
April 6, 2011
October 3, 2017
October 2010
July 2013   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01330368 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children
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.
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.
Observational
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:
urine
Non-Probability Sample
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
Systemic Lupus Erythematosus
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
June 2017
July 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
5 Years to 21 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01330368
10-007747
No
Not Provided
Not Provided
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Jon Burnham, MD, MSCE Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
September 2017