Bone Disease in Severely Burned Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-10-31

Study Completion Date

2008-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Burn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Compare bone density of severly burned children to normal non-burned population

Group Type ACTIVE_COMPARATOR

Tetracycline

Intervention Type DRUG

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

Duel Energy X-Ray Absorptiometry (DEXA)

Intervention Type RADIATION

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

Bone Biopsy

Intervention Type PROCEDURE

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.

Interventions

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Tetracycline

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

Intervention Type DRUG

Duel Energy X-Ray Absorptiometry (DEXA)

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

Intervention Type RADIATION

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.

Intervention Type PROCEDURE

Other Intervention Names

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Duel Energy X-Ray Absorptiometry

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No