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Bone Microarchitecture in Women With and Without Fracture

Bone Microarchitecture in Women With and Without Fracture

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01049191
Acronym
mMRI
Enrollment
78
Registered
2010-01-14
Start date
2008-10-31
Completion date
2010-05-31
Last updated
2015-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture, Osteoporosis

Keywords

Osteoporosis, Fracture, microMRI, Bone architecture, Bone matrix, Bone and Bones, Magnetic Resonance Imaging

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, 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.

Interventions

None listed

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Postmenopausal women volunteers age ≥ 50 years * normal BMD or osteopenia (T-score \> -2.5 at the L1-4 spine, proximal femur and 1/3rd radius) by DXA. * sustained a fragility fracture of the spine, hip or wrist, defined as a fracture occurring with everyday activities including a fall from standing height or less. * Historical radiographic documentation of fracture will be obtained. * Criteria as defined above without prior fracture, age and bone density matching a participant in the fracture group

Exclusion criteria

* metabolic bone disease * malignancy * renal failure * use of medications which alter bone turnover * diseases/conditions leading to the non-dominant arm disuse * contraindications to MRI.

Design outcomes

Primary

MeasureTime frame
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.18 months

Secondary

MeasureTime frame
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.18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026