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Bone Disease in Severely Burned Children

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ClinicalTrials.gov Identifier: NCT00591162
Recruitment Status : Terminated (terminated due to PI lab/duties affected by natural disaster.)
First Posted : January 11, 2008
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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

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

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  (Clinical Trial)
Actual Enrollment : 254 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bone Disease in Severely Burned Children
Study Start Date : October 1992
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Diseases Burns
U.S. FDA Resources

Arm Intervention/treatment
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.



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


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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591162


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

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00591162     History of Changes
Other Study ID Numbers: 92-304
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: June 2014

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

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