Systemic Lupus ErythematosusNCT01330368
Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children
An observational study of Systemic Lupus Erythematosus, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 5 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, SLE, Lupus, children with SLE
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
Age and sex specific z-scores for lumbar spine (L2) volumetric bone mineral density (BMD) (trabecular and total) and vertebral volume.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionJul 2013
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon Burnham, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330368
- Sponsor's protocol ID
- 10-007747
- Status last verified
- Sep 2017
- First submitted
- 14 Dec 2010
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children
- ClinicalTrials.gov ID
- NCT01330368
- Acronym / sponsor ID
- 10-007747
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, SLE, Lupus, children with SLE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Burnham, MD, MSCE principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.