Assessment of Cortical Bone Mechanics Technology (CBMT) Fracture Discrimination Capability

Summary

Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue leading to bone fragility (i.e., weakness) and an increased risk for fracture. Bone strength is a critical factor in a bone's ability to resist fracture and is clearly an important outcome in studies of osteoporosis. The current standard for assessing bone health and diagnosing osteoporosis is to use dual-energy x-ray absorptiometry (DXA) to quantify the areal bone mineral density (BMD), typically at the hip and spine. However, DXA-derived BMD has limited discriminatory accuracy for distinguishing individuals that experience fragility fracture from those who do not. One well known limitation of DXA-derived BMD is that it does not adequately assay bone strength. There is a critical unmet need to identify persons more accurately with diminished bone strength who are at high risk of experiencing a fragility fracture in order to determine an appropriate therapy. A potential new diagnostic approach to assess skeletal health and improve osteoporosis diagnosis is the use of Cortical Bone Mechanics Technology (CBMT). CBMT leverages multifrequency vibration analysis to conduct a noninvasive, dynamic 3-point bending test that makes direct, mechanical measurements of ulnar cortical bone. Data indicates that CBMT-derived ulnar flexural rigidity accurately estimates ulnar whole bone strength and provides information about cortical bone that is unique and independent of DXA-derived BMD. However, the clinical utility of CBMT-derived flexural rigidity has not yet been demonstrated. The investigators have designed a clinical study to assess the accuracy of CBMT-derived ulnar flexural rigidity in discriminating post-menopausal women who have suffered a fragility fracture from those who have not. These data will be compared to DXA-derived peripheral and central measures of BMD obtained from the same subjects.

Conditions

• Osteoporosis
• Osteopenia or Osteoporosis
• Osteoporosis, Postmenopausal
• Osteoporosis Risk
• Osteoporotic Fractures
• Fragility Fracture
• Bone Fracture

Interventions

DIAGNOSTIC_TEST

Cortical Bone Mechanics Technology

Cortical Bone Mechanics Technology (CBMT). CBMT testing will be performed bilaterally, and flexural rigidity (EI) will be calculated. If a participant has fractured a wrist or forearm bone in the prior 1-year, then only the arm that was not fractured will be tested. During testing, participants will lie supine in the CBMT instrument.

Sponsors & Collaborators

• Indiana University School of Medicine

  collaborator OTHER

• University of Florida

  collaborator OTHER

• University of South Florida

  collaborator OTHER

• Ohio University

  lead OTHER

Principal Investigators

• Brian Clark, PhD · Ohio Musculoskeletal and Neurological Institute (OMNI) at Ohio University

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2023-10-30

Completion

2023-10-30

Countries

• United States

Study Locations