Bone Disease in Severely Burned Children | NCT00591162

Studies
Bone Disease in Severely Burned Children

NCT00591162

Sponsor

The University of Texas Medical Branch, Galveston

Status

Terminated

Last Update Posted

Jun 6, 2014Estimated

Enrollment

254Actual

Phase

Phase 2Phase 3

Conditions

Burn

Interventions

Tetracycline
Duel Energy X-Ray Absorptiometry (DEXA)
Bone Biopsy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

terminated due to PI lab/duties affected by natural disaster.

Expanded Access Info

Start Date

Oct 1992

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Dec 26, 2007

First Submission Date that Met QC Criteria

Jan 10, 2008

First Posted Date

Jan 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2014

Last Update Posted Date

Jun 6, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

254Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Compare bone density of severly burned children to normal non-burned population	Drug: Tetracycline Radiation: Duel Energy X-Ray Absorptiometry (DEXA) Procedure: Bone Biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tetracycline	Drug	Two courses of IV Tetracycline(10mg./kg./day for two days)separated by a two week interval.	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Klein Gordon, M.D.	U.T.M.B.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
U.T.M.B.		Galveston	Texas	77550	United States

Type	Date	Date Unknown
Release	Sep 30, 2015
Reset	Nov 2, 2015
Release	Nov 26, 2019
Reset	Dec 13, 2019
Release	Jun 15, 2023
Reset	Jul 6, 2023
Release	Jul 6, 2023
Reset	Jul 26, 2023
Release	Mar 27, 2026
Reset	Apr 15, 2026

Submission Tracking

Estimated Results First Submitted Date

Sep 30, 2015

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 30, 2015			Nov 2, 2015
Nov 26, 2019

ID	Term
D002056	Burns

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D013752	Tetracycline

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

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Browse Branches

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