Bone Disease in Severely Burned Children
Bone metabolism is adversely affected by severe burns in children for a period of time...
Brief Summary
Official Title: “Bone Disease in Severely Burned Children”
Bone metabolism is adversely affected by severe burns in children for a period of time.
- Study Type: Interventional
- Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: October 2011
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Tetracycline
- Two courses of IV Tetracycline(10mg./kg./day for two days)separated by a two week interval.
- Radiation: DEXA
- DEXA before discharge from acute admission and again one year post burn.
- Procedure: Bone Biopsy
- Bone biopsy to be taken in the operation room at the last skin grafting operation at the site of the illiac crest. A second bone biopsy will be taken one year later post discharge from the acute admission.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Compare bone density of severly burned children to normal non-burned population
Outcome Measures for this Clinical Trial
Primary Measures
- Determine Bone Health(bone growth,strength,and content) in burn injured patients.
- Time Frame: Admission to Burn Unit up to eighteen years old.
Safety Issue?: No
- Time Frame: Admission to Burn Unit up to eighteen years old.
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 5 Years
Maximum Age for this Clinical Trial: 18 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: The University of Texas, Galveston Other
Overall Clinical Trial Officials and Contacts
Klein Gordon, M.D. Principal Investigator U.T.M.B.
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00591162
Study ID Number: 92-304
ClinicalTrials.gov Identifier: NCT00591162
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00591162
