Bone Disease in Severely Burned Children

This study has been suspended.

( Suspended due to PI lab/duties affected by natural disaster. This is temporary until PI lab returns or another PI/lab is assigned. )

First Received on December 26, 2007. Last Updated on August 13, 2010 History of Changes

Sponsor:	The University of Texas, Galveston
Information provided by:	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT00591162

Purpose

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

Condition	Intervention	Phase
Burn	Drug: Tetracycline Radiation: DEXA Procedure: Bone Biopsy	Phase II Phase III

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Bone Diseases Burns

Drug Information available for: Tetracycline Tetracycline hydrochloride

U.S. FDA Resources

Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	350
Study Start Date:	October 1992
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Compare bone density of severly burned children to normal non-burned population	Drug: Tetracycline Two courses of IV Tetracycline(10mg./kg./day for two days)separated by a two week interval. Radiation: 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 illiac crest. A second bone biopsy will be taken one year later post discharge from the acute admission.

Arms

Assigned Interventions

Active Comparator: 1

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

Drug: Tetracycline

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

Radiation: 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 illiac crest. A second bone biopsy will be taken one year later post discharge from the acute admission.

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.

Eligibility

Ages Eligible for Study:	5 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591162

Locations

United States, Texas
U.T.M.B.
Galveston, Texas, United States, 77550

Sponsors and Collaborators

The University of Texas, Galveston

Investigators

Principal Investigator:

Klein Gordon, M.D.

U.T.M.B.

More Information

No publications provided

Responsible Party:	Gordon Klein M.D., University of Texas Medical Branch, Galveston,Texas
ClinicalTrials.gov Identifier:	NCT00591162 History of Changes
Other Study ID Numbers:	92-304
Study First Received:	December 26, 2007
Last Updated:	August 13, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:

Bone,Dexa,Parathyroid,Diuretic,Tetracycline

Additional relevant MeSH terms:

Bone Diseases
Musculoskeletal Diseases
Tetracycline
Protein Synthesis Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012