Bone Disease in Severely Burned Children
Bone metabolism is adversely affected by severe burns in children for a period of time.
Radiation: Duel Energy X-Ray Absorptiometry (DEXA)
Procedure: Bone Biopsy
|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|
- 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 ]
|Study Start Date:||October 1992|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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 AbsorptiometryProcedure: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591162
|United States, Texas|
|Galveston, Texas, United States, 77550|
|Principal Investigator:||Klein Gordon, M.D.||U.T.M.B.|