Bone Microarchitecture in Women With and Without Fracture (mMRI)

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01049191
First received: January 12, 2010
Last updated: July 15, 2010
Last verified: July 2010
  Purpose

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
Osteoporosis
Fracture

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Bone Microarchitecture in Women With and Without Fracture

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples are being collected to obtain chemistry panel and test related to skeletal status. These samples will not be retained or stored after these analyses are completed.


Estimated Enrollment: 78
Study Start Date: October 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fracture
Subjects experiencing a prior osteoporotic fracture.
Control
These will be age and bone density matched controls to the fracture group.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Seventy-two postmenopausal volunteers age ≥ 50 years will be recruited from existing databases of ~3500 women with expressed interested in research. All will have normal BMD or osteopenia (T-score > -2.5 at the L1-4 spine, proximal femur and 1/3rd radius) by DXA. Thirty-six will have 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. Thirty-six women without fracture will serve as age- race- and BMD-matched controls. Age will be matched to within 6 months; BMD in grams/cm2 at the non-dominant ultra-distal radius will be matched to within 5%.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049191

Locations
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
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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
  More Information

No publications provided

Responsible Party: Administrative Office, University of Wisconsin Institute for Clinical and Translational Research
ClinicalTrials.gov Identifier: NCT01049191     History of Changes
Other Study ID Numbers: 2008-0177
Study First Received: January 12, 2010
Last Updated: July 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Osteoporosis
Fracture
microMRI
Bone architecture
Bone matrix
Bone and Bones
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 15, 2014