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Bone Disease in Severely Burned Children

This study has been terminated.
(terminated due to PI lab/duties affected by natural disaster.)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston Identifier:
First received: December 26, 2007
Last updated: June 5, 2014
Last verified: June 2014
Bone metabolism is adversely affected by severe burns in children for a period of time.

Condition Intervention Phase
Drug: Tetracycline
Radiation: Duel Energy X-Ray Absorptiometry (DEXA)
Procedure: Bone Biopsy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bone Disease in Severely Burned Children

Resource links provided by NLM:

Further study details as provided by The University of Texas Medical Branch, Galveston:

Primary Outcome Measures:
  • Determine Bone Health(bone growth,strength,and content) in burn injured patients. [ Time Frame: Admission to Burn Unit up to eighteen years old. ]

Enrollment: 254
Study Start Date: October 1992
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Compare bone density of severly burned children to normal non-burned population
Drug: Tetracycline
Two courses of IV Tetracycline(10mg./kg./day for two days)separated by a two week interval.
Radiation: Duel Energy X-Ray Absorptiometry (DEXA)
DEXA before discharge from acute admission and again one year post burn.
Other Name: Duel Energy X-Ray Absorptiometry
Procedure: Bone Biopsy
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.

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.

Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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.
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Please refer to this study by its identifier: NCT00591162

United States, Texas
Galveston, Texas, United States, 77550
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Principal Investigator: Klein Gordon, M.D. U.T.M.B.
  More Information

Responsible Party: The University of Texas Medical Branch, Galveston Identifier: NCT00591162     History of Changes
Other Study ID Numbers: 92-304
Study First Received: December 26, 2007
Last Updated: June 5, 2014

Keywords provided by The University of Texas Medical Branch, Galveston:
Bone, Dexa, Parathyroid, Diuretic, Tetracycline

Additional relevant MeSH terms:
Bone Diseases
Musculoskeletal Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017