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
|Condition or disease||Intervention/treatment||Phase|
|Burn||Drug: Tetracycline Radiation: Duel Energy X-Ray Absorptiometry (DEXA) Procedure: Bone Biopsy||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||254 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: 1
Compare bone density of severly burned children to normal non-burned population
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.
- Determine Bone Health(bone growth,strength,and content) in burn injured patients. [ Time Frame: Admission to Burn Unit up to eighteen years old. ]
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
|United States, Texas|
|Galveston, Texas, United States, 77550|
|Principal Investigator:||Klein Gordon, M.D.||U.T.M.B.|