Bone Disease in Severely Burned Children

Phase 3TerminatedNCT00591162

The University of Texas Medical Branch, Galveston254 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

254

Conditions

Burn

Interventions

TetracyclineDRUG

Two courses of IV Tetracycline(10mg./kg./day for two days)separated by a two week interval.

Duel Energy X-Ray Absorptiometry (DEXA)RADIATION

DEXA before discharge from acute admission and again one year post burn.

Bone BiopsyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

U.T.M.B.

Galveston, Texas, United States

Outcomes

Primary Outcomes

Determine Bone Health(bone growth,strength,and content) in burn injured patients.

Time frame: Admission to Burn Unit up to eighteen years old.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.