Spine Quantitative Computed Tomography (QCT) (Spine QCT)
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00762879
First received: September 26, 2008
Last updated: July 15, 2016
Last verified: July 2016
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Purpose
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.
| Condition |
|---|
|
Juvenile Idiopathic Arthritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children |
Resource links provided by NLM:
Further study details as provided by Children's Hospital of Philadelphia:
Primary Outcome Measures:
- Lumbar spine volumetric Bone Mineral Density (vBMD) and vertebral size will vary according to sex, age and pubertal stage. [ Time Frame: same day ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Children with JIA will have lower vertebral stiffness and strength, compared with controls. [ Time Frame: same day ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
urine
| Enrollment: | 127 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | December 2016 |
| Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| No treatment |
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.
Eligibility| Ages Eligible for Study: | 5 Years to 21 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
200 control patients and 30 study patients
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00762879
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762879
Locations
| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
| Principal Investigator: | Jon Burnham, MD | Children's Hospital of Philadelphia |
More Information
| Responsible Party: | Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT00762879 History of Changes |
| Other Study ID Numbers: | 2007-10-5528 |
| Study First Received: | September 26, 2008 |
| Last Updated: | July 15, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital of Philadelphia:
|
Juvenile Idiopathic Arthritis JIA Arthritis Osteoporosis Osteoporosis in Children |
Additional relevant MeSH terms:
|
Arthritis Osteoporosis Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases Bone Diseases, Metabolic |
Bone Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on September 30, 2016