CompletedNot Applicable

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

United States394 participantsStarted 2022-07-01

Plain-language 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.

Who can participate

Age range50 Years – 80 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion and Exclusion Criteria for Subjects Who Have Experienced a Fragility Fracture (Cases) 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. * 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. 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. * The subject will be excluded if they…

What they're measuring

Discriminatory Accuracy of CBMT vs. BMD

Timeframe: 1 Day

CBMT's Added Value

Timeframe: 1 Day

Trial details

NCT IDNCT05721898

SponsorOhio University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-10-30