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Bone Disease in Severely Burned Children
This study has been terminated.
(terminated due to PI lab/duties affected by natural disaster.)
Sponsor:
The University of Texas Medical Branch, Galveston
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT00591162
First received: December 26, 2007
Last updated: June 5, 2014
Last verified: June 2014
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Purpose
Bone metabolism is adversely affected by severe burns in children for a period of time.
| Condition | Intervention | Phase |
|---|---|---|
| Burn | Drug: Tetracycline Radiation: Duel Energy X-Ray Absorptiometry (DEXA) Procedure: Bone Biopsy | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Bone Disease in Severely Burned Children |
Resource links provided by NLM:
Further study details as provided by The University of Texas Medical Branch, Galveston:
Primary Outcome Measures:
- Determine Bone Health(bone growth,strength,and content) in burn injured patients. [ Time Frame: Admission to Burn Unit up to eighteen years old. ]
| Enrollment: | 254 |
| Study Start Date: | October 1992 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Compare bone density of severly burned children to normal non-burned population
|
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 Name: 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.
|
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.
Eligibility| Ages Eligible for Study: | 5 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00591162
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591162
Locations
| United States, Texas | |
| U.T.M.B. | |
| Galveston, Texas, United States, 77550 | |
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
| Principal Investigator: | Klein Gordon, M.D. | U.T.M.B. |
More Information
| Responsible Party: | The University of Texas Medical Branch, Galveston |
| ClinicalTrials.gov Identifier: | NCT00591162 History of Changes |
| Other Study ID Numbers: |
92-304 |
| Study First Received: | December 26, 2007 |
| Last Updated: | June 5, 2014 |
Keywords provided by The University of Texas Medical Branch, Galveston:
|
Bone, Dexa, Parathyroid, Diuretic, Tetracycline |
Additional relevant MeSH terms:
|
Bone Diseases Musculoskeletal Diseases Tetracycline Anti-Bacterial Agents |
Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 25, 2017