Back to resultsBone Disease in Severely Burned Children
Primary Purpose
Burn
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tetracycline
Duel Energy X-Ray Absorptiometry (DEXA)
Bone Biopsy
Sponsored by
About this trial
This is an interventional treatment trial for Burn focused on measuring Bone, Dexa, Parathyroid, Diuretic, Tetracycline
Eligibility 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.
Sites / Locations
- U.T.M.B.
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
1
Arm Description
Compare bone density of severly burned children to normal non-burned population
Outcomes
Primary Outcome Measures
Determine Bone Health(bone growth,strength,and content) in burn injured patients.
Secondary Outcome Measures
Full Information
NCT ID
NCT00591162
First Posted
December 26, 2007
Last Updated
June 5, 2014
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT00591162
Brief Title
Bone Disease in Severely Burned Children
Official Title
Bone Disease in Severely Burned Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
terminated due to PI lab/duties affected by natural disaster.
Study Start Date
October 1992 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bone metabolism is adversely affected by severe burns in children for a period of time.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn
Keywords
Bone, Dexa, Parathyroid, Diuretic, Tetracycline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Compare bone density of severly burned children to normal non-burned population
Intervention Type
Drug
Intervention Name(s)
Tetracycline
Intervention Description
Two courses of IV Tetracycline(10mg./kg./day for two days)separated by a two week interval.
Intervention Type
Radiation
Intervention Name(s)
Duel Energy X-Ray Absorptiometry (DEXA)
Other Intervention Name(s)
Duel Energy X-Ray Absorptiometry
Intervention Description
DEXA before discharge from acute admission and again one year post burn.
Intervention Type
Procedure
Intervention Name(s)
Bone Biopsy
Intervention Description
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 Measure Information:
Title
Determine Bone Health(bone growth,strength,and content) in burn injured patients.
Time Frame
Admission to Burn Unit up to eighteen years old.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klein Gordon, M.D.
Organizational Affiliation
U.T.M.B.
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.T.M.B.
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
12. IPD Sharing Statement
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Bone Disease in Severely Burned Children
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