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

NCT ID: NCT00663143

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-12-31

Brief 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. 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.

Conditions

Osteoporosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Stromal Cell Sample

Stromal Cells Sample

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University SOM

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Emory Crawford Long Hospital

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00006692

Identifier Type: -

Identifier Source: org_study_id