Trial | NCT00591162  Report issue

Official Title

Bone Disease in Severely Burned Children

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Indication/Condition

    Burn

  • Intervention/Treatment

    tetracycline ...

  • Study Participants

    254
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 Started
Oct 31
1992
Primary Completion
Jun 30
2008
Study Completion
Jun 30
2008
Last Update
Jun 06
2014
Estimate

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.

  • Other names: 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 iliac crest. A second bone biopsy will be taken one year later post discharge from the acute admission.

1 Active Comparator

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

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.
No Results Posted