NCT00591162

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 1992

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1992

Completed
15.2 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

Enrollment Period

15.7 years

First QC Date

December 26, 2007

Last Update Submit

June 5, 2014

Conditions

Burn

Keywords

Bone, Dexa, Parathyroid, Diuretic, Tetracycline

Outcome Measures

Primary Outcomes (1)

  • Determine Bone Health(bone growth,strength,and content) in burn injured patients.

    Admission to Burn Unit up to eighteen years old.

Study Arms (1)

1

ACTIVE COMPARATOR

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

Drug: TetracyclineRadiation: Duel Energy X-Ray Absorptiometry (DEXA)Procedure: Bone Biopsy

Interventions

TetracyclineDRUG

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

1
Duel Energy X-Ray Absorptiometry (DEXA)RADIATION

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

Also known as: Duel Energy X-Ray Absorptiometry
1
Bone BiopsyPROCEDURE

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

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children age 5-18 years old with at least 40% or more of their body burned.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.B.

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Tetracycline

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Klein Gordon, M.D.

    U.T.M.B.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

October 1, 1992

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 6, 2014

Record last verified: 2014-06

Locations

US(1)