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NCT05721898 · ClinicalTrials.gov registry record
Assessment of Cortical Bone Mechanics Technology (CBMT) Fracture Discrimination Capability
A clinical trial, sponsored by Ohio University.
- Completed
- Registry status
- 394
- Enrollment target
NCT05721898: Completed study, sponsored by Ohio University.
NCT05721898 is a clinical trial that has completed, run by Ohio University. The registered enrollment target is 394 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05721898 has completed, sponsored by Ohio University.
- COMPLETED
- Registry status
- 394 participants
- Enrollment target
Study 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.
Primary Outcome
Discriminatory accuracy of ulnar flexural rigidity in comparison to the bone mineral density.
Interventions
- DIAGNOSTIC_TEST Cortical Bone Mechanics Technology
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 394 participants |
| Start Date | 2022-07-01 |
| Est. Completion | 2023-10-30 |
What the finished NCT05721898 record still lists
NCT05721898 is an observational study that tracks outcomes without assigning an intervention. The registered 394 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Cortical Bone Mechanics Technology is the first listed.
NCT05721898 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05721898 about?
NCT05721898 is a clinical study titled "Assessment of Cortical Bone Mechanics Technology (CBMT) Fracture Discrimination Capability". 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...
What is the current status of trial NCT05721898?
This trial is currently completed. The enrollment target is 394 participants. The study started on 2022-07-01. Estimated completion is 2023-10-30.
What interventions are being tested in trial NCT05721898?
The interventions under investigation include: Cortical Bone Mechanics Technology (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05721898?
This trial is sponsored by Ohio University, which has 51 total clinical trials registered on ClinicalTrials.gov.
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