ClinicalTrials.gov
ClinicalTrials.gov Menu

Spine Quantitative Computed Tomography (QCT) (Spine QCT)

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.
ClinicalTrials.gov Identifier: NCT00762879
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
Juvenile Idiopathic Arthritis

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 Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 127 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 : April 2008
Actual Primary Completion Date : January 2014
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
No treatment


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Lumbar spine volumetric Bone Mineral Density (vBMD) and vertebral size will vary according to sex, age and pubertal stage. [ Time Frame: same day ]

Secondary Outcome Measures :
  1. Children with JIA will have lower vertebral stiffness and strength, compared with controls. [ Time Frame: same day ]

Biospecimen Retention:   Samples Without DNA
urine

Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00762879     History of Changes
Other Study ID Numbers: 07-005528
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017

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
Metabolic Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases