Ignite Creation Date:
2024-05-05 @ 10:09 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01049191
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2010-01-12
Brief Title:
Bone Microarchitecture in Women With and Without Fracture
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Bone Microarchitecture in Women With and Without Fracture
Status:
COMPLETED
Status Verified Date:
2010-07
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:
mMRI
Brief Summary:
Osteoporosis is a common disorder of compromised bone strength causing 40-50 of women and 25 of men to sustain fragility fractures during their lifetime The reduction of bone strength in osteoporotic people results from loss of bone density and deterioration of bone quality Bone quality is a complex amalgamation including macro- and micro-architecture mineralization turnover and damage accumulation Currently medications to reduce fracture risk are prescribed primarily on the basis of bone mineral density BMD measurement Unfortunately currently available BMD measurement technologies do not detect the aforementioned properties of bone quality as such less than half of individuals who sustain osteoporotic fractures are classified as osteoporotic by currently available diagnostic tools Clearly measures to enhance identification of those at high fracture risk are needed High-resolution magnetic resonance imaging HR-MRI technology such as that provided by MicroMRI Inc has outstanding potential to be such a tool Therefore our long-term goal is to evaluate and optimize the use of HR-MRI in fracture risk prediction this pilot work is an essential step in attaining this goal
This research will investigate 72 postmenopausal women with normal or osteopenic BMD by dual-energy x-ray absorptiometry DXA 36 with prior low-trauma fractures will be compared with 36 age- race- and BMD matched women without fracture We hypothesize that 1 Women with fractures will have evidence of microarchitectural deterioration on HR-MRI and 2 Newly developed more rapid MRI sequences designed at the UW will provide similar trabecular microstructure information more rapidly than the currently used albeit investigational technology produced by MicroMRI Inc
Our specific aims are to a Evaluate differences in MicroMRI parameters of trabecular microstructure bone volume fraction trabecular thickness surfacecurve ratio and erosion index between age- race- and BMD-matched postmenopausal women with and without fracture b Correlate T2 relaxation time a rapid indirect MRI measure of trabecular density and microstructure with BMD measured by DXA and microstructural parameters measured by MicroMRI As an exploratory aim we will investigate HR-MRI parameters of trabecular microstructure obtained using a newly developed rapid MRI sequence referred to as IDEAL-FSE with parameters obtained using the currently available MicroMRI Inc sequence
This research will investigate 72 postmenopausal women with normal or osteopenic BMD by dual-energy x-ray absorptiometry DXA 36 with prior low-trauma fractures will be compared with 36 age- race- and BMD matched women without fracture We hypothesize that 1 Women with fractures will have evidence of microarchitectural deterioration on HR-MRI and 2 Newly developed more rapid MRI sequences designed at the UW will provide similar trabecular microstructure information more rapidly than the currently used albeit investigational technology produced by MicroMRI Inc
Our specific aims are to a Evaluate differences in MicroMRI parameters of trabecular microstructure bone volume fraction trabecular thickness surfacecurve ratio and erosion index between age- race- and BMD-matched postmenopausal women with and without fracture b Correlate T2 relaxation time a rapid indirect MRI measure of trabecular density and microstructure with BMD measured by DXA and microstructural parameters measured by MicroMRI As an exploratory aim we will investigate HR-MRI parameters of trabecular microstructure obtained using a newly developed rapid MRI sequence referred to as IDEAL-FSE with parameters obtained using the currently available MicroMRI Inc sequence
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