Ignite Creation Date:
2024-05-05 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00703417
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2008-06-19
Brief Title:
Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients A Pilot Study
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients A Pilot Study
Status:
COMPLETED
Status Verified Date:
2011-06
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:
For this cross-sectional case control pilot study 30 women 55-75 years old with type II diabetes will be recruited Diabetes will be defined as self-report of diabetes previously diagnosed by a physician use of hypoglycemic medications or fasting glucose 126 mgdl 70mM in accordance with the American Diabetes Association criteria The diabetic patient population will be divided into 2 groups patients with status post low energy fractures of the proximal humerus the proximal femur the ankle and the foot n10 versus diabetic patients with no fractures or low energy trauma fracture history n10 An additional group of 10 diabetic postmenopausal women will be recruited and will have magnetic resonance imaging MRI of the lower back only Caucasian Asian and Hispanic women will be combined since a previous study suggested that BMD is very similar in these 3 population and that ethnic differences are minimal In addition a population of 10 age-matched BMI-matched race-matched healthy women without osteoporotic fractures will be examined In all of these volunteers a medical history will be obtained to ensure good health status and rule out chronic diseases that would have an impact on bone metabolism Patients will undergo MRI QCT and high-resolution peripheral quantitative computed tomography HR-pQCT examinations to determine bone mineral density and bone structurequality
The hypothesis of this pilot project is that type II diabetic patients with and without low-energy fractures have a different trabecular bone architecture and composition which is also different when compared to normal age-matched healthy patients Architectural differences in these three patient groups may be visualized with high resolution MRI and high-resolution peripheral quantitative computed tomography HR-pQCT and will be most pronounced at the calcaneus and the distal tibia Analyzing structure parameters obtained from high resolution MRI and spectroscopy may improve our understanding of the pathophysiology of diabetic bone disease and the prediction of fracture risk in an elderly diabetic population
The hypothesis of this pilot project is that type II diabetic patients with and without low-energy fractures have a different trabecular bone architecture and composition which is also different when compared to normal age-matched healthy patients Architectural differences in these three patient groups may be visualized with high resolution MRI and high-resolution peripheral quantitative computed tomography HR-pQCT and will be most pronounced at the calcaneus and the distal tibia Analyzing structure parameters obtained from high resolution MRI and spectroscopy may improve our understanding of the pathophysiology of diabetic bone disease and the prediction of fracture risk in an elderly diabetic population
Detailed Description:
None
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