- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00762879
Spine Quantitative Computed Tomography (QCT) (Spine QCT)
September 29, 2017 updated by: Children's Hospital of Philadelphia
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 a chronic illness called Juvenile Idiopathic Arthritis (JIA).
JIA is a childhood disease that causes swollen joints that are often stiff and painful.
JIA affects about 1 in 1,000 children age 16 and younger.
Study Overview
Status
Completed
Conditions
Detailed Description
Children with chronic illnesses are at risk for bone fragility due to inflammation, glucocorticoid therapy, physical activity limitation, malnutrition, and pubertal delay.
The impact of low bone mass during childhood may be immediate, resulting in childhood fractures, or delayed, due to suboptimal peak bone mass attainment.
Study Type
Observational
Enrollment (Actual)
127
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
200 control patients and 30 study patients
Description
Inclusion Criteria:
- for JIA patients: subjects age 5-21 Drawn from Dr. Burnham's prospective cohort study of bone health in 101 children with arthritis.
- for Control patients: subjects age 5-21 Controls will be a 50% male/female
Exclusion Criteria:
- for JIA patients: Subjects with JIA will be excluded if they have conditions or drug exposure unrelated to JIA and known to impact growth or bone health.
- for Control patients: 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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No treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lumbar spine volumetric Bone Mineral Density (vBMD) and vertebral size will vary according to sex, age and pubertal stage.
Time Frame: same day
|
same day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Children with JIA will have lower vertebral stiffness and strength, compared with controls.
Time Frame: same day
|
same day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jon Burnham, MD, Children's Hospital of Philadelphia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
September 26, 2008
First Submitted That Met QC Criteria
September 26, 2008
First Posted (Estimate)
September 30, 2008
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-005528
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Juvenile Idiopathic Arthritis
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Institut National de la Santé Et de la Recherche...CompletedSystemic-Onset Juvenile Idiopathic ArthritisFrance
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