Bone Disease in Severely Burned Children
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ClinicalTrials.gov Identifier: NCT00591162 |
Recruitment Status
:
Terminated
(terminated due to PI lab/duties affected by natural disaster.)
First Posted
: January 11, 2008
Last Update Posted
: June 6, 2014
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Condition or disease | Intervention/treatment | Phase |
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Burn | Drug: Tetracycline Radiation: Duel Energy X-Ray Absorptiometry (DEXA) Procedure: Bone Biopsy | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 254 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Bone Disease in Severely Burned Children |
Study Start Date : | October 1992 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Compare bone density of severly burned children to normal non-burned population
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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.
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- Determine Bone Health(bone growth,strength,and content) in burn injured patients. [ Time Frame: Admission to Burn Unit up to eighteen years old. ]

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Ages Eligible for Study: | 5 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591162
United States, Texas | |
U.T.M.B. | |
Galveston, Texas, United States, 77550 |
Principal Investigator: | Klein Gordon, M.D. | U.T.M.B. |
Responsible Party: | The University of Texas Medical Branch, Galveston |
ClinicalTrials.gov Identifier: | NCT00591162 History of Changes |
Other Study ID Numbers: |
92-304 |
First Posted: | January 11, 2008 Key Record Dates |
Last Update Posted: | June 6, 2014 |
Last Verified: | June 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 |