Effect of Thiazolidinediones on Human Bone
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|ClinicalTrials.gov Identifier: NCT00927355|
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : June 2, 2014
Last Update Posted : March 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Osteoblast Adipocytes Bone Density Osteocalcin Adiponectin Mesenchymal Stem Cells||Drug: Pioglitazone Drug: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effects of Thiazolidinediones on Human Bone Marrow Stromal Cell Differentiation Capacity:In Vitro and In Vivo- A Pilot Study|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||July 2011|
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.
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.
- 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 ]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 ]
- Bone Mineral Density [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927355
|United States, Georgia|
|Grady Diabetes Clinic|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Natasha B Khazai, M.D.||Emory University|