Bone Disease in Severely Burned Children

This study has been terminated.
(terminated due to PI lab/duties affected by natural disaster.)
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00591162
First received: December 26, 2007
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

Bone metabolism is adversely affected by severe burns in children for a period of time.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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, 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. ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591162

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

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00591162     History of Changes
Other Study ID Numbers: 92-304
Study First Received: December 26, 2007
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bone Diseases
Musculoskeletal Diseases
Tetracycline
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014