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

Completed

Conditions studied: Osteoporosis, Osteopenia or Osteoporosis, Osteoporosis, Postmenopausal, Osteoporosis Risk, Osteoporotic Fractures, Fragility Fracture, Bone Fracture

In brief

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.

Key facts

Study ID

NCT05721898

Run by

Ohio University

People needed

394

Starts

2022-07-01

Expected to finish

2023-10-30

Last updated by the study team

2023-11-01

Who can join

Age: 50 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• 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).
• If, in the opinion of a site PI, the subject is inappropriate for the scientific purposes of this study. For instance, a high fall risk patient due to an existing neurological disorder (e.g., Parkinsons disease, ALS, etc.) would be excluded.
• Inclusion and Exclusion Criteria for Subjects Who Have Not Experienced a Fragility Fracture (Controls) Inclusion Criteria
• 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.
• Self-reports not experiencing 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.
• Physically able to safely participate in the study activities.
• Able to provide informed consent.
• Exclusion Criteria
• 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.

Where it is running

• University of Florida — Gainesville, Florida, United States
• University of Florida — Jacksonville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Indiana Center for Musculoskeletal Health — Indianapolis, Indiana, United States
• Ohio Musculoskeletal and Neurological Institute at Ohio University — Athens, Ohio, United States

Full record on ClinicalTrials.gov

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