NCT00762879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

5.8 years

First QC Date

September 26, 2008

Last Update Submit

September 29, 2017

Conditions

Juvenile Idiopathic Arthritis

Keywords

Juvenile Idiopathic ArthritisJIAArthritisOsteoporosisOsteoporosis in Children

Outcome Measures

Primary Outcomes (1)

  • Lumbar spine volumetric Bone Mineral Density (vBMD) and vertebral size will vary according to sex, age and pubertal stage.

    same day

Secondary Outcomes (1)

  • Children with JIA will have lower vertebral stiffness and strength, compared with controls.

    same day

Study Arms (1)

No treatment

Eligibility Criteria

Age5 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

200 control patients and 30 study patients

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

MeSH Terms

Conditions

Arthritis, JuvenileArthritisOsteoporosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone Diseases, MetabolicBone DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jon Burnham, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

April 1, 2008

Primary Completion

January 1, 2014

Study Completion

June 1, 2017

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations

US(1)