Bone Microarchitecture in Women With and Without Fracture

NCT ID: NCT01049191

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-05-31

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.

Conditions

Osteoporosis; Fracture

Study Design

• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Fracture

Subjects experiencing a prior osteoporotic fracture.

No interventions assigned to this group

Control

These will be age and bone density matched controls to the fracture group.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Kijowski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Department of Radiology

Neil C Binkley, MD

Role: STUDY_DIRECTOR

University of Wisconsin Osteoporosis Clinical Research Center

Michael J Tuite, MD

Role: STUDY_DIRECTOR

University of Wisconsin Department of Radiology

Locations

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, United States

University of Wisconsin Osteoporosis Clinical and Research Program

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

2008-0177

Identifier Type: -

Identifier Source: org_study_id