Effect of Diabetic Medications on Bone Metabolism
Subjects with diabetes and pre-diabetes are said to have increased bone loss when compared to the general population. Pioglitazone a thiazolidinedione, is a Food and Drug Administration (FDA) approved oral anti-diabetic agent for the treatment of type 2 diabetes. Though there are many benefits for using thiazolidinediones in the treatment of type 2 diabetes, there is data that indicates that rosiglitazone therapy results in a significant decrease in total body bone mineral density in mice. Whether it is true in humans is not clear. If the animal data can be extrapolated to humans, thiazolidinediones may pose a significant risk of adverse effects on bone. This study hypothesizes that treatment with the thiazolidinedione pioglitazone may result in significant reduction in bone mineral density. The aims of this are: 1. to evaluate the effect of pioglitazone on skeletal health; 2. to measure the bone mineral density (BMD) of the spine and hip, as well as bone turnover markers, at different times of persons taking thiazolidinediones and others not taking them; 3. to determine the change in BMD and bone turnover markers within different groups at different times; and 4. to compare these changes.
Type 2 Diabetes Mellitus
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Effect of Thiazolidinediones on Skeletal Health|
- changes in BMD and bone turn over markers in subjects with diabetes on pioglitazone compared to those who are not on pioglitazone [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Urine and serum samples collected for the study will be spin and stored at -70 degree C and assays run intermittently
|Study Start Date:||October 2006|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
140 subjects with type 2 diabetes on pioglitazone.
140 subjects with type 2 diabetes not on pioglitazone.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467285
|Principal Investigator:||Subhashini Yaturu, MD||Albany VA Medical Center Samuel S. Stratton, Albany, NY|