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: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2011

More closely monitored biochemical and radiologic parameters of bone and mineral metabolism will increase the likelihood of earlier detection of abnomalities 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

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

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

Lead Sponsor: The University of Texas, Galveston

Overall Clinical Trial Officials and Contacts

Klein Gordon, M.D. Principal Investigator U.T.M.B.  

Overall Contact: Gordon Klein, M.D. 409-772-1689 gklein@utmb.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

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