Effect of Thiazolidinediones on Human Bone
We will prospectively study 2 groups of diabetic patients treated with pioglitazone or placebo for 26 weeks. Bone marrow aspirates will be obtained from these patients at baseline and after 26 weeks of treatment, and hBMCs will be isolated from these bone marrow aspirations. The ability of hBMCs to differentiate into osteoblast and adipocytes lineages will be compared before and after treatment with pioglitazone and compared to placebo. In parallel, clinical markers of bone formation and resorption as well as bone mineral density will be assessed before and after 26 weeks of treatment. Primary endpoint for this study will be detection of change in number of osteoblasts or adipocytes from cultured hBMCs between study groups and within each group.
Mesenchymal Stem Cells
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
|Official Title:||Effects of Thiazolidinediones on Human Bone Marrow Stromal Cell Differentiation Capacity:In Vitro and In Vivo- A Pilot Study|
- Percent Change in Number of Osteoblast and Adipocyte Colony Forming Units Cultured From Bone Marrow Stem Cells Harvested 6 Months After Treatment With Study Drug Compared to Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]To determine the effect of PIO (pioglitazone) on BMSC (bone marrow stem cell) lineage choice in vivo, a bone marrow aspiration was obtained from patients at baseline and after 6 months of treatment with PIO or placebo. The bone marrow was used for ex vivo CFU-OB (Colony forming units-Osteoblast) and CFU-AD assays using the same protocol described for the in vitro studies previously. We also analyzed the number of total colonies per patient at both baseline and final visit.
- βCTX (Carboxy Terminal Collagen Crosslinks), Osteocalcin, and Adiponectin. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Bone Mineral Density [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||July 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Pioglitazone
half of the diabetic patients will be randomized to pioglitazone treatment for 6 months starting out with 15mg qd for 4 weeks and dose increased to 30mg (2 tablets) qday if no adverse effects noted at the four week mark by study physician.
6 month treatment with pioglitazone 15mg for four weeks with dose increased to 30mg if no adverse effects (swelling of lower extremities, liver enzyme elevation) noted at the four week mark.
Other Name: Actos
Placebo Comparator: Placebo
The other half will be randomized to placebo for 6 months. The placebo pills also start out with one "15mg) pill qday and are increased to 2 tablets ("30mg") qday after 4 weeks if no adverse effects are noted by study physician.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927355
|United States, Georgia|
|Grady Diabetes Clinic|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Natasha B Khazai, M.D.||Emory University|