- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00591162
Bone Disease in Severely Burned Children
June 5, 2014 updated by: The University of Texas Medical Branch, Galveston
Bone metabolism is adversely affected by severe burns in children for a period of time.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
More closely monitored biochemical and radiologic parameters of bone and mineral metabolism will increase the likelihood of earlier detection of abnormalities and possible therapeutic interventions.
Study Type
Interventional
Enrollment (Actual)
254
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Galveston, Texas, United States, 77550
- U.T.M.B.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children age 5-18 years old with at least 40% or more of their body burned.
Exclusion Criteria:
- Anyone with a burn covering less than 40% of the body or whose burn covers the front of both hipbones.
- Anyone younger than 5 years old, anyone with a history of cancer or other metabolic disease process, or anyone who is pregnant or has an allergy to Tetracycline will also be excluded.
- Anyone who has participated in an investigational drug trial within the past 60 days from date of admission will be excluded from this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Compare bone density of severly burned children to normal non-burned population
|
Two courses of IV Tetracycline(10mg./kg./day for two days)separated by a two week interval.
DEXA before discharge from acute admission and again one year post burn.
Other Names:
Bone biopsy to be taken in the operation room at the last skin grafting operation at the site of the iliac crest.
A second bone biopsy will be taken one year later post discharge from the acute admission.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine Bone Health(bone growth,strength,and content) in burn injured patients.
Time Frame: Admission to Burn Unit up to eighteen years old.
|
Admission to Burn Unit up to eighteen years old.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Klein Gordon, M.D., U.T.M.B.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1992
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
January 10, 2008
First Posted (Estimate)
January 11, 2008
Study Record Updates
Last Update Posted (Estimate)
June 6, 2014
Last Update Submitted That Met QC Criteria
June 5, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 92-304
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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