Spine Quantitative Computed Tomography (QCT) (Spine QCT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00762879
First received: September 26, 2008
Last updated: July 7, 2014
Last verified: July 2014
  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: January 2015
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
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
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, see Learn About Clinical Studies.

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

No publications provided

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 7, 2014
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 Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Bone Diseases, Metabolic
Bone Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014