Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04765631
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2020-07-23
Brief Title:
Type 2 Diabetes and Bone Microarchitecture
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Type 2 Diabetes and Bone Microarchitecture in Men and Women a Case-control Study
Status:
COMPLETED
Status Verified Date:
2020-07
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:
Type 2 diabetes is a major public health problem associated with an increased risk of fractures Diabetes even appears to be the most important predictor of low kinetic fractures in men and women and the risk of hip fracture in type 2 diabetics is increased by 40 to 50 with often more serious consequences post-operative complications longer hospital stays increased mortality rate
Currently the risk of fractures is estimated by the measure of areal bone mineral density aBMD and T-score However in diabetics aBMD is not decreased and even paradoxically increased Indeed aBMD is 5-10 higher in type 2 diabetic patients compared to non-diabetic subjects which suggests that the assessment of fracture risk in these patients is underestimated The High Resolution peripheral Quantitative Computed Tomography HR-pQCT 3D bone imaging technique has a resolution close to the size of the bone trabeculae It is used to assess volumetric bone mineral density vBMD and bone microarchitecture at the tibia and distal radius and enables a better estimation of the fracture risk compared to the measurement of aBMD Our hypothesis is that bone microarchitecture is altered in type 2 diabetic patients explaining the increased risk of fracture in this population compared to non-diabetics
We propose to set up a descriptive case control study nestled in 3 cohorts of men and women QUALYOR OFELY and STRAMBO to compare the bone micro-architecture measured by HR-pQCT at the level of the tibia and distal radius in type 2 diabetics compared to non-diabetic subjects from the same cohorts
Currently the risk of fractures is estimated by the measure of areal bone mineral density aBMD and T-score However in diabetics aBMD is not decreased and even paradoxically increased Indeed aBMD is 5-10 higher in type 2 diabetic patients compared to non-diabetic subjects which suggests that the assessment of fracture risk in these patients is underestimated The High Resolution peripheral Quantitative Computed Tomography HR-pQCT 3D bone imaging technique has a resolution close to the size of the bone trabeculae It is used to assess volumetric bone mineral density vBMD and bone microarchitecture at the tibia and distal radius and enables a better estimation of the fracture risk compared to the measurement of aBMD Our hypothesis is that bone microarchitecture is altered in type 2 diabetic patients explaining the increased risk of fracture in this population compared to non-diabetics
We propose to set up a descriptive case control study nestled in 3 cohorts of men and women QUALYOR OFELY and STRAMBO to compare the bone micro-architecture measured by HR-pQCT at the level of the tibia and distal radius in type 2 diabetics compared to non-diabetic subjects from the same cohorts
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None