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

NCT05721898 | Completed

• 1 other identifier: 21-F-1
• Study Type: observational
• Target: 394
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Osteoporosis; Bone strength; Fracture

Outcome Measures

Primary Outcomes (2)

• Discriminatory Accuracy of CBMT vs. BMD

  Discriminatory accuracy of ulnar flexural rigidity in comparison to the bone mineral density.

  1 Day

• CBMT's Added Value

  Binomial logistic regression's Walt coefficient to quantify how ulnar flexural rigidity and areal BMD predicts group membership (cases and controls).

  1 Day

Study Arms (2)

Fracture Cases

Fragility Fracture Cases: Post-menopausal females between 50-80 years who have experienced a fragility fracture of the arms (including wrist fractures) or legs (including hip, pelvis, or ankle fractures) after the age of 50 years. Fractures of the spine, digits, toes or face will not be considered. A fragility fracture is operationally define based on self-report of an arm or leg fracture caused by falls from a height \<6 inches. A fragility fracture will not count if it is associated with 1) running, bicycling or other similar fast-moving activity such as sports subjects, 2) being struck by a falling or otherwise quickly moving heavy object, or 3) a motor vehicle accident. Insufficiency/stress fractures will not be included. Body mass index between 18.5 and 35 kg/m2.

Diagnostic Test: Cortical Bone Mechanics Technology

Non-Fracture Controls

Controls: Post-menopausal females between 50-80 years who have not experienced a fracture at any site after the age of 40 years (does not include fractures of the digits, toes or face). Does not self-report losing more than 1.5 inches in stature (height) in the previous 15 years. Body mass index between 18.5 and 35 kg/m2.

Diagnostic Test: Cortical Bone Mechanics Technology

Interventions

Cortical Bone Mechanics Technology DIAGNOSTIC_TEST

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.

Fracture Cases; Non-Fracture Controls

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will investigate and compare the abilities of OsteoDXs Cortical Bone Mechanics Technology (CBMT) and dual-energy x-ray absorptiometry (DXA) to discriminate between women ages 50-80 who have recently experienced a fragility fracture (n=138) and age-, BMI- and race-matched women who have not experienced a similar fracture (n=276 \[1:2 allocation ratio\]). Control subject matching will be done retrospectively with the goal being to match each case with controls that are within \~ 5 years, 3 BMI units, and of the same race.

You may not qualify if:

• Female.
• Age range: 50 to 80 years at recruitment. All subjects must self-report that their last menses occurred at least 24-months prior to enrollment.
• Has experienced a fragility fracture of the arms (including wrist fractures) or legs (including hip, pelvis, or ankle fractures) after the age of 50 years. Fractures of the spine, digits, toes or face will not be considered. A fragility fracture is operationally define based on self-report of an arm or leg fracture caused by falls from a height \<6 inches. A fragility fracture will not count if it is associated with 1) running, bicycling or other similar fast-moving activity such as sports subjects, 2) being struck by a falling or otherwise quickly moving heavy object, or 3) a motor vehicle accident. Insufficiency/stress fractures will not be included.
• Body mass index between 18.5 and 35 kg/m2.
• Physically able to safely participate in the study activities.
• Able to provide informed consent.
• Failure to provide informed consent.
• Has had bilateral hip replacements.
• Lives in a nursing home; persons living in assisted or independent housing will not be excluded.
• Self-reported type 1 diabetes.
• Unable to communicate because of severe hearing loss or speech disorder.
• Self-reports being told by a physician that they have a terminal illness.
• The subject will be excluded if they answer yes to the following question: Do you have an active rotator cuff tear, had shoulder surgery in the past 12-months, or experience severe shoulder, wrist, or elbow joint pain on a regular basis?
• Use of systemic glucocorticoids for more than 6-months in the prior one year.
• Self-reported diseases that could interfere with bone metabolism. For example, osteomalacia, bone cancer, myeloma, Pagets disease, hyper parathyroidism, hyperthyroidism not treated, severe renal (stage 4+ chronic kidney disease, history of dialysis, kidney transplant, etc.) or hepatic insufficiency, prolonged immobilization (more than 2 months in the previous year).

Sponsors & Collaborators

• Ohio University: lead
• Indiana University School of Medicine: collaborator
• University of Florida: collaborator
• University of South Florida: collaborator

Study Sites (5)

University of Florida

Gainesville, Florida, 32601, United States

Location

University of Florida

Jacksonville, Florida, 32209, United States

Location

University of South Florida

Tampa, Florida, 33620, United States

Location

Indiana Center for Musculoskeletal Health

Indianapolis, Indiana, 46202, United States

Location

Ohio Musculoskeletal and Neurological Institute at Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal; Osteoporotic Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Study Officials

• Brian Clark, PhD

  Ohio Musculoskeletal and Neurological Institute (OMNI) at Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 10, 2023
• Study Start: July 1, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)