Thiazolidinediones (TZD) Bone Loss and the Effects on Bone Marrow Differentiation and Osteoblast Formation (TZDBONE)
Recruitment status was Active, not recruiting
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. .
|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|
- 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 ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||July 2014|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Procedure: Stromal Cells Sample
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.
Please refer to this study by its ClinicalTrials.gov 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|
|Principal Investigator:||Guillermo Umpierrez, MD||Emory University SOM|