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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 26, 2007 | ||||||||
| Last Updated Date | February 28, 2009 | ||||||||
| Start Date ICMJE | October 1992 | ||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Determine Bone Health(bone growth,strength,and content) in burn injured patients. [ Time Frame: Admission to Burn Unit up to eighteen years old. ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00591162 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Bone Disease in Severely Burned Children | ||||||||
| Official Title ICMJE | Bone Disease in Severely Burned Children | ||||||||
| Brief Summary | Bone metabolism is adversely affected by severe burns in children for a period of time. |
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| Detailed Description | More closely monitored biochemical and radiologic parameters of bone and mineral metabolism will increase the likelihood of earlier detection of abnomalities and possible therapeutic interventions. |
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| Study Phase | Phase II, Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Burn | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | Active Comparator: Compare bone density of severly burned children to normal non-burned population | ||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 350 | ||||||||
| Estimated Completion Date | October 2011 | ||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 5 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00591162 | ||||||||
| Responsible Party | Gordon Klein M.D., University of Texas Medical Branch, Galveston,Texas | ||||||||
| Study ID Numbers ICMJE | 92-304 | ||||||||
| Study Sponsor ICMJE | The University of Texas, Galveston | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | The University of Texas, Galveston | ||||||||
| Verification Date | February 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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