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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00762879
Other study ID # 07-005528
Secondary ID
Status Completed
Phase N/A
First received September 26, 2008
Last updated September 29, 2017
Start date April 2008
Est. completion date June 2017

Study information

Verified date September 2017
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date June 2017
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 21 Years
Eligibility 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 Design


Locations

Country Name City State
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lumbar spine volumetric Bone Mineral Density (vBMD) and vertebral size will vary according to sex, age and pubertal stage. same day
Secondary Children with JIA will have lower vertebral stiffness and strength, compared with controls. same day
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