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CompletedNCT01330368Updated Oct 3, 2017

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

An observational study in Systemic Lupus Erythematosus, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 5 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-03.

Sponsored by Children's Hospital of Philadelphia · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
32
Ages
5 Years to 21 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • Systemic Lupus Erythematosus
  • SLE
  • Lupus
  • children with SLE
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 32 is below the median of 174 across 446 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
32 participants (actual)
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Age and sex specific z-scores for lumbar spine (L2) volumetric bone mineral density (BMD) (trabecular and total) and vertebral volume.

    Time frame: 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.

    Time frame: 2 years

07

Study locations

1 site
  • The Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01330368
Lead sponsor
Children's Hospital of Philadelphia
Responsible party
Sponsor
First posted
Apr 6, 2011
Start date
Oct 2010
Primary completion
Jul 2013
Completion
Jun 2017
Last update
Oct 3, 2017

Study contacts

Jon Burnham, MD, MSCE
principal investigator · Children's Hospital of Philadelphia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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