Bone Microarchitecture in Women With and Without Fracture (mMRI)
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|ClinicalTrials.gov Identifier: NCT01049191|
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : October 5, 2015
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, surface/curve 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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||78 participants|
|Official Title:||Bone Microarchitecture in Women With and Without Fracture|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Subjects experiencing a prior osteoporotic fracture.
These will be age and bone density matched controls to the fracture group.
- Evaluate difference in MicroMRI parameters of trabecular microstructure (bone volume, surface/curve ratio and erosion index) between age-, race- and BMD-matched postmenopausal women with and without fracture. [ Time Frame: 18 months ]
- 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. [ Time Frame: 18 months ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049191
|United States, Wisconsin|
|University of Wisconsin Hospitals and Clinics|
|Madison, Wisconsin, United States, 53705|
|University of Wisconsin Osteoporosis Clinical and Research Program|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Richard Kijowski, MD||University of Wisconsin Department of Radiology|
|Study Director:||Neil C Binkley, MD||University of Wisconsin Osteoporosis Clinical Research Center|
|Study Director:||Michael J Tuite, MD||University of Wisconsin Department of Radiology|