OsteoporosisTZDBONENCT00663143
Thiazolidinediones (TZD) Bone Loss and the Effects on Bone Marrow Differentiation and Osteoblast Formation
An observational study of Osteoporosis, run by Emory University at 3 sites in United States.
Trial summary
Thiazolidinediones (TZDs) are a commonly used antidiabetic drugs currently used by over a million patients in the United States. Recent studies have shown that treatment with TZD may increase the risk of bone fractures. The cause of bone loss is not known. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Stromal Cells Sample
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2009to Dec 2010
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with 1) traumatic mandibular (jaw) fracture who will undergo bone grafting or 2) trauma patients who will undergo intra-medullary rod placement for traumatic limb fractures will be considered as potential candidates in the study
Who may be able to join
- Males or females between the ages of 18 and 80 years undergoing ileac crest bone graft to repair traumatic mandible fracture.
- Patients admitted for elective or emergency surgery or trauma.
Who cannot join
- Subjects with history of decompensated diabetes (blood glucose > 200 mg/dl)
- Critically ill patients with multi-organ failure, relevant hepatic disease or impaired renal function (serum creatinine ≥ 2.0 mg/dl)
- HIV
- Hemolytic anemia and/or hematocrit < 28%
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory Crawford Long Hospital
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Thiazolidinedione-Induced Bone Loss: Effects on Bone Marrow Stromal Cell Differentiation Capacity and Osteoblast Formation
Thiazolidinediones (TZDs) are a commonly used antidiabetic drugs currently used by over a million patients in the United States. Recent studies have shown that treatment with TZD may increase the risk of bone fractures. The cause of bone loss is not known. We believe that TZD may cause increased accumulation of fat in the bone marrow, which may cause decrease bone formation and weak bones. .
Read the detailed description
This study aims to determine if TZDs increase the amount of fat and decrease the number of bone producing cells in the bone marrow.
A total of 5 subjects who require surgery for mandible (jaw) fracture and bone graft will be recruited. Some patients who will undergo mandible surgery will require a bone graft. In this procedure, a small piece of bone from the hip is placed in the mandible. In this study, a small amount of bone marrow fluid (5 mL or 1 teaspoon) will be obtained after the bone graft is completed. Obtaining the bone marrow will not result in additional pain or health problems. The effect of TZD on bone marrow and bone forming cells will be studied. The cells obtained during surgery will be grown at Dr Beck's laboratory at Emory University School of Medicine.
A working hypothesis suggests that the increased fracture risk in patients taking TZDs is the result of TZDs altering the differentiation capacity of bone marrow stromal cells pushing them towards the adipocyte lineage at the cost of osteoblast formation thereby decreasing bone formation.
Study AIM:To determine whether TZD exposure in vitro alters bone formation and the differentiation capacity of bone marrow stromal cells by promoting adipocyte lineage differentiation and lowering osteoblast formation.
- Conditions
- Osteoporosis
- Being tested
- Stromal Cells Sample
- Keywords
- investigate, TZD exposure, in vitro, alters, bone, formation, differentiation, capacity, bone marrow, stromal cells
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stromal Cells SampleProcedure or surgery
Human Bone Marrow Stromal Cells will be obtained from 5 patients. Stromal cells will be obtained from subjects undergoing bone graft procedure to repair traumatic mandible fractures. Bone graft specimens will be obtained from the ileac crest. This will allow easy access to bone marrow specimen without additional pain or complications. A total of 5 ml of bone marrow will be obtained from each patient.
| Study group | Role | What they receive |
|---|---|---|
| Stromal Cell Sample | Not described Receives: Procedure: Stromal Cells Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether TZD exposure in vitro alters bone formation and the differentiation capacity of bone marrow stromal cells by promoting adipocyte lineage differentiation and lowering osteoblast formation
Measured: once all subjects have been recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startJul 2009
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663143
- Sponsor's protocol ID
- IRB00006692
- Acronym
- TZDBONE
- Status last verified
- Mar 2015
- First submitted
- 18 Apr 2008
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thiazolidinedione-Induced Bone Loss: Effects on Bone Marrow Stromal Cell Differentiation Capacity and Osteoblast Formation
- ClinicalTrials.gov ID
- NCT00663143
- Acronym / sponsor ID
- TZDBONE / IRB00006692
- Conditions
- Osteoporosis
- Keywords
- investigate, TZD exposure, in vitro, alters, bone, formation, differentiation, capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Apr 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.
Thiazolidinediones (TZDs) are a commonly used antidiabetic drugs currently used by over a million patients in the United States. Recent studies have shown that treatment with TZD may increase the risk of bone fractures. The cause of bone loss is not known. We believe that TZD may cause increased accumulation of fat in the bone marrow, which may cause decrease bone formation and weak bones. .
Detailed description
This study aims to determine if TZDs increase the amount of fat and decrease the number of bone producing cells in the bone marrow.
A total of 5 subjects who require surgery for mandible (jaw) fracture and bone graft will be recruited. Some patients who will undergo mandible surgery will require a bone graft. In this procedure, a small piece of bone from the hip is placed in the mandible. In this study, a small amount of bone marrow fluid (5 mL or 1 teaspoon) will be obtained after the bone graft is completed. Obtaining the bone marrow will not result in additional pain or health problems. The effect of TZD on bone marrow and bone forming cells will be studied. The cells obtained during surgery will be grown at Dr Beck's laboratory at Emory University School of Medicine.
A working hypothesis suggests that the increased fracture risk in patients taking TZDs is the result of TZDs altering the differentiation capacity of bone marrow stromal cells pushing them towards the adipocyte lineage at the cost of osteoblast formation thereby decreasing bone formation.
Study AIM:To determine whether TZD exposure in vitro alters bone formation and the differentiation capacity of bone marrow stromal cells by promoting adipocyte lineage differentiation and lowering osteoblast formation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stromal Cell Sample | – | Procedure: Stromal Cells Sample |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with 1) traumatic mandibular (jaw) fracture who will undergo bone grafting or 2) trauma patients who will undergo intra-medullary rod placement for traumatic limb fractures will be considered as potential candidates in the study
Key inclusion criteria (2 listed)
- Males or females between the ages of 18 and 80 years undergoing ileac crest bone graft to repair traumatic mandible fracture.
- Patients admitted for elective or emergency surgery or trauma.
Key exclusion criteria (6 listed)
- Subjects with history of decompensated diabetes (blood glucose > 200 mg/dl)
- Critically ill patients with multi-organ failure, relevant hepatic disease or impaired renal function (serum creatinine ≥ 2.0 mg/dl)
- HIV
- Hemolytic anemia and/or hematocrit < 28%
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the 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 |
|---|---|---|
| Stromal Cells SampleHuman Bone Marrow Stromal Cells will be obtained from 5 patients. Stromal cells will be obtained from subjects undergoing bone graft procedure to repair traumatic mandible fractures. Bone graft specimens will be obtained from the ileac crest. This will allow easy access to bone marrow specimen without additional pain or complications. A total of 5 ml of bone marrow will be obtained from each patient. | Procedure or surgery | Stromal Cell Sample |
Primary outcome
To determine whether TZD exposure in vitro alters bone formation and the differentiation capacity of bone marrow stromal cells by promoting adipocyte lineage differentiation and lowering osteoblast formation
Time frame: once all subjects have been recruited
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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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.
Guillermo Umpierrez, MD principal investigator
Emory University SOM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Emory University at 3 sites 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine whether TZD exposure in vitro alters bone formation and the differentiation capacity of bone marrow stromal cells by promoting adipocyte lineage differentiation and lowering osteoblast formation (time frame: once all subjects have been recruited). 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 1 Apr 2015.