Bone Disease in Severely Burned Children

Burn Clinical Trial

Official title:

Bone Disease in Severely Burned Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00591162
• Other study ID #: 92-304
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: December 26, 2007
• Last updated: June 5, 2014
• Start date: October 1992
• Est. completion date: June 2008

Study information

• Verified date: June 2014
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 254
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases
• Burn

Intervention

Drug:
• Tetracycline
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.

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.

Locations

Country	Name	City	State
United States	U.T.M.B.	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine Bone Health(bone growth,strength,and content) in burn injured patients.		Admission to Burn Unit up to eighteen years old.