Bone Disease in Severely Burned Children

The University of Texas System (UT)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Burn

Treatments: Procedure: Bone Biopsy; Drug: Tetracycline; Radiation: Duel Energy X-Ray Absorptiometry (DEXA)

Study type: Interventional

Funder types: Other

Identifiers

NCT00591162

92-304

Details and patient eligibility

About

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

Full 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.

Enrollment: 254 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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254 participants in 1 patient group

1

Active Comparator group

Description:

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

Treatment:

Procedure: Bone Biopsy

Radiation: Duel Energy X-Ray Absorptiometry (DEXA)

Drug: Tetracycline