Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children

NCT ID: NCT01330368

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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The purpose of this research study is to measure bone mass in children with SLE using different measurement techniques. Children with chronic illnesses are at risk of bone fragility. This is important because bone fragility can result in childhood fractures especially children with SLE. Therefore better diagnosis technique can lead to better management of bone health.

Conditions

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jon Burnham, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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10-007747

Identifier Type: -

Identifier Source: org_study_id