BurnPhase 2/3NCT00591162
Bone Disease in Severely Burned Children
A Phase 2/3 study testing Tetracycline, Duel Energy X-Ray Absorptiometry (DEXA) and Bone Biopsy in people with Burn, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Bone metabolism is adversely affected by severe burns in children for a period of time. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Burn
- What is being tested?
- Tetracycline, Duel Energy X-Ray Absorptiometry (DEXA) and Bone Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1992to Jun 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children age 5-18 years old with at least 40% or more of their body burned.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Bone metabolism is adversely affected by severe burns in children for a period of time.
Read the 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.
- Conditions
- Burn
- Being tested
- Tetracycline, Duel Energy X-Ray Absorptiometry (DEXA), Bone Biopsy
- Keywords
- Bone, Dexa, Parathyroid, Diuretic, Tetracycline
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetracyclineDrug
Two courses of IV Tetracycline(10mg./kg./day for two days)separated by a two week interval.
Duel Energy X-Ray Absorptiometry (DEXA)Radiation
Also called Duel Energy X-Ray Absorptiometry
DEXA before discharge from acute admission and again one year post burn.
Bone BiopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Compare bone density of severly burned children to normal non-burned population Receives: Drug: Tetracycline; Radiation: Duel Energy X-Ray Absorptiometry (DEXA); Procedure: Bone Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Bone Health(bone growth,strength,and content) in burn injured patients.
Measured: Admission to Burn Unit up to eighteen years old.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startOct 1992
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: terminated due to PI lab/duties affected by natural disaster.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klein Gordon, M.D., Principal investigator, U.T.M.B.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591162
- Sponsor's protocol ID
- 92-304
- Status last verified
- Jun 2014
- First submitted
- 26 Dec 2007
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Disease in Severely Burned Children
- ClinicalTrials.gov ID
- NCT00591162
- Acronym / sponsor ID
- 92-304
- Conditions
- Burn
- Keywords
- Bone, Dexa, Parathyroid, Diuretic, Tetracycline
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated due to PI lab/duties affected by natural disaster.
- Enrolment
- 254 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Oct 1992
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Tetracycline, Radiation: Duel Energy X-Ray Absorptiometry (DEXA), Procedure: Bone BiopsyCompare bone density of severly burned children to normal non-burned population |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children age 5-18 years old with at least 40% or more of their body burned.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetracyclineTwo courses of IV Tetracycline(10mg./kg./day for two days)separated by a two week interval. | Drug | 1 |
| Duel Energy X-Ray Absorptiometry (DEXA)Also: Duel Energy X-Ray AbsorptiometryDEXA before discharge from acute admission and again one year post burn. | Radiation | 1 |
| Bone BiopsyBone 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. | Procedure or surgery | 1 |
Primary outcome
Determine Bone Health(bone growth,strength,and content) in burn injured patients.
Time frame: Admission to Burn Unit up to eighteen years old.
Results and safety
The study was stopped early (reason given: terminated due to PI lab/duties affected by natural disaster.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klein Gordon, M.D. principal investigator
U.T.M.B.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tetracycline, Duel Energy X-Ray Absorptiometry (DEXA) and Bone Biopsy in people with Burn, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: terminated due to PI lab/duties affected by natural disaster.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Bone Health(bone growth,strength,and content) in burn injured patients. (time frame: Admission to Burn Unit up to eighteen years old.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014.