Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Thiazolidinediones (TZD) Bone Loss and the Effects on Bone Marrow Differentiation and Osteoblast Formation (TZDBONE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Emory University.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University Identifier:
First received: April 18, 2008
Last updated: February 7, 2014
Last verified: March 2011

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. .

Condition Intervention
Procedure: Stromal Cells Sample

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Thiazolidinedione-Induced Bone Loss: Effects on Bone Marrow Stromal Cell Differentiation Capacity and Osteoblast Formation

Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: May 2008
Estimated Study Completion Date: July 2014
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Stromal Cells Sample
    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.
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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males or females between the ages of 18 and 80 years undergoing ileac crest bone graft to repair traumatic mandible fracture.
  2. Patients admitted for elective or emergency surgery or trauma.

Exclusion Criteria:

  1. Subjects with history of decompensated diabetes (blood glucose > 200 mg/dl)
  2. Critically ill patients with multi-organ failure, relevant hepatic disease or impaired renal function (serum creatinine ≥ 2.0 mg/dl)
  3. HIV
  4. Hemolytic anemia and/or hematocrit < 28%
  5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
  6. Pregnancy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00663143

United States, Georgia
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Emory University Hospital
Atlanta, Georgia, United States, 30322
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Principal Investigator: Guillermo Umpierrez, MD Emory University SOM
  More Information

No publications provided

Responsible Party: Guillermo Umpierrez, Principal Investigator, Emory University Identifier: NCT00663143     History of Changes
Other Study ID Numbers: IRB00006692, IRB#e6692
Study First Received: April 18, 2008
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
if TZD exposure
in vitro
bone marrow
stromal cells processed this record on March 01, 2015