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COMPLETED
NCT00467285

Effect of Diabetic Medications on Bone Metabolism

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

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.

Official title: Effect of Thiazolidinediones on Skeletal Health

Key Details

Gender

All

Age Range

30 Years - 55 Years

Study Type

OBSERVATIONAL

Enrollment

96

Start Date

2006-10

Completion Date

2009-09

Last Updated

2026-08-13

Healthy Volunteers

Yes