Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467285
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2007-04-26
Brief Title:
Effect of Diabetic Medications on Bone Metabolism
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effect of Thiazolidinediones on Skeletal Health
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The prevalence rate of diabetes among veterans is 16 in general and 27 at out medical center compared to 63 among United States population Subjects with diabetes and prediabetes said to have increased bone loss 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 Most of the pleiotropic effects of teh thiazolidinediones are beneficial in atherosclerosis and cancer in addition to improving insulin resistance Data from studies in mice show that rosiglitazone and pioglitazone therapy results in a significant decrease in total body bone mineral density was observed Whether it is true in humans is not clear There are no prospective studies to date Subjects with diabetes are already at an increased risk for femoral fractures If the animal data can be can be extrapolated to humans thiazolidinedione pioglitazone may result in significant risk of adverse skeletal effects This study hypothesizes that treatment with the thiazolidinedione pioglitazone may result in a significant reduction in bone mineral density The aims of the study include 1 To prospectively evaluate the effect of pioglitazone on skeletal health we will study 140 subjects with diabetes receiving pioglitazone as part of their diabetes management and compare them with 140 diabetic controls matched for age sex body mass index BMI smoking and alcohol history not treated with pioglitazone 2 To measure the bone mineral density by DXA at AP spine and hip as well as bone turnover markers-procollagen type 1C-terminal propeptide P1CP and procollagen type 1N-terminal propeptide P1NP bone specific alkaline phosphatase osteocalcin plasma C-telopeptide CTx and N-telopeptide NTx at baseline six and 12 months of follow-up 3 To determine the change in BMD and bone turnover markers within each group from baseline to follow-up at six and 12 months 4 To compare the changes in the BMD and bone turnover markers between groups at baseline and follow-up at six and 12 months
Subjects Prospectively study 140 subjects with type 2 diabetes and on pioglitazone age and sex matched controls
Sample Size The sample size is based on the primary objective of comparing the levels bone turnover markers and bone mineral density changes in diabetes with or without avandia
Number of visits 140 subjects with diabetes and on pioglitazone and 140 subjects with diabetes not on pioglitazone
1 Subjects will be studies at three visits
2 The procedures to be done include assessment of bone mineral density measurement by dual X-ray absorptiometry DXA measurement of bone turnover markers like serum osteocalcin and urinary N-telopeptide after the informed consent About 15ml one tablespoonful of blood will be drawn at each visit for the study
3 All the baseline measurements will be repeated at 6 months and at one year
4 Statistical analysis of the data will be done to compare the changes in bone turnover markers and bone mineral density between the two groups
Site of the study Overton Brooks VAMC Diabetics clinic and Primary care clinics
If our hypothesis is proven correct subjects with diabetes requiring thiazolidinediones should have bone turnover markers and BMD measurement at baseline and have serial follow up Identification of subjects at high risk will allow health care providers to initiate necessary protective measures to protect the bone to decrease the fracture risk
Potential Impact on Veterans Health Care Identification of subjects at high risk will allow health care providers to initiate necessary preventive measures to protect the bone and decrease the risk of fractures or avoid the use of TZDs altogether in select patients Since the prevalence of diabetes is very high among veterans evaluation of a possible risk of skeletal health with the use of pioglitazone is highly relevant to VA health care
Subjects Prospectively study 140 subjects with type 2 diabetes and on pioglitazone age and sex matched controls
Sample Size The sample size is based on the primary objective of comparing the levels bone turnover markers and bone mineral density changes in diabetes with or without avandia
Number of visits 140 subjects with diabetes and on pioglitazone and 140 subjects with diabetes not on pioglitazone
1 Subjects will be studies at three visits
2 The procedures to be done include assessment of bone mineral density measurement by dual X-ray absorptiometry DXA measurement of bone turnover markers like serum osteocalcin and urinary N-telopeptide after the informed consent About 15ml one tablespoonful of blood will be drawn at each visit for the study
3 All the baseline measurements will be repeated at 6 months and at one year
4 Statistical analysis of the data will be done to compare the changes in bone turnover markers and bone mineral density between the two groups
Site of the study Overton Brooks VAMC Diabetics clinic and Primary care clinics
If our hypothesis is proven correct subjects with diabetes requiring thiazolidinediones should have bone turnover markers and BMD measurement at baseline and have serial follow up Identification of subjects at high risk will allow health care providers to initiate necessary protective measures to protect the bone to decrease the fracture risk
Potential Impact on Veterans Health Care Identification of subjects at high risk will allow health care providers to initiate necessary preventive measures to protect the bone and decrease the risk of fractures or avoid the use of TZDs altogether in select patients Since the prevalence of diabetes is very high among veterans evaluation of a possible risk of skeletal health with the use of pioglitazone is highly relevant to VA health care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None