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

NCT00663143 | Completed DMC

• 1 other identifier: IRB00006692
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 3

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. .

Conditions

Osteoporosis

Keywords

investigate; TZD exposure; in vitro; alters; bone; formation; differentiation; capacity; bone marrow; stromal cells

Outcome Measures

Primary Outcomes (1)

• 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

  once all subjects have been recruited

Study Arms (1)

Stromal Cell Sample

Procedure: Stromal Cells Sample

Interventions

Stromal Cells Sample 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.

Stromal Cell Sample

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone Marrow

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Guillermo Umpierrez, MD

  Emory University SOM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: July 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

US (3)