Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children
1 other identifier
observational
32
1 country
1
Brief Summary
The purpose of this study is to compare healthy children to children who have systemic lupus erythematosus (SLE). SLE is a childhood disease that has high risk for low bone mass and vertebral compression fractures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 14, 2010
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedOctober 3, 2017
September 1, 2017
2.8 years
December 14, 2010
September 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Age and sex specific z-scores for lumbar spine (L2) volumetric bone mineral density (BMD) (trabecular and total) and vertebral volume.
2 years
Secondary Outcomes (1)
Mean lumbar spine stiffness and strength in children with SLE and healthy controls correlation between standard and low dose lumbar spine.
2 years
Eligibility Criteria
200 control patients (124 controls participated in unique protocol ID: 2007-10-5528 data will be used for this study, we will be trying to recruit about 76 control patients for this study) and 30 study patients with SLE
You may qualify if:
- For SLE subjects: Subjects age 5-21 drawn from rheumatology clinic at Children's Hospital of Philadelphia diagnosed with SLE for at least 1 month. Also subjects with no known vertebral compression fracture of L2.
- For Control subjects: Subjects age 5-21. Controls will be a 50% male/female.
You may not qualify if:
- For SLE subjects: Subjects with SLE will be excluded if they have conditions or drug exposure unrelated to SLE and known to impact growth or bone health.
- For Control subjects: 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
Biospecimen
urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Burnham, MD, MSCE
Children's Hospital of Philadelphia
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2010
First Posted
April 6, 2011
Study Start
October 1, 2010
Primary Completion
July 1, 2013
Study Completion
June 1, 2017
Last Updated
October 3, 2017
Record last verified: 2017-09