BUSS03: Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment
Study Details
Study Description
Brief Summary
Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of osteoporosis and predict prevalent osteoporotic fractures. Measurements derived from the BUSS parameters will be able to discriminate between postmenopausal women with osteoporotic fractures when compared to matched controls without history of osteoporotic fracture.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
One of several studies to develop and clinically validate a novel ultrasonographic device, BUSS, for the assessment of osteoporosis and fracture risk.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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With osteoporotic fracture Approximately 100 postmenopausal women that have been enrolled in a population-based case-control study that have experienced a clinically-diagnosed fracture of thoracolumbar spine or distal forearm due to minimal or moderate trauma based on review on their inpatient and outpatient medical records will be enrolled. |
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Without osteoporotic fracture Approximately 100 control women will have no history of a prior spine, hip, or wrist fracture. |
Outcome Measures
Primary Outcome Measures
- Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women. [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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postmenopausal women with osteoporotic fracture at spine or wrist
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postmenopausal women no history of fracture at spine or wrist
Exclusion Criteria:
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women with a history of metabolic disease
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stroke
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tibia fracture or surgery
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BMI ≥ 35 kg/m2
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Teriparatide use currently or within the past 6 months,
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Any skin issues (open wounds or rashes, and/or skin infections) of the tibial area.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Mayo Clinic Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Artann Laboratories
- National Institutes of Health (NIH)
- National Institute on Aging (NIA)
- Mayo Clinic
Investigators
- Principal Investigator: Armen Sarvazyan, Ph.D., D.Sc., Artann Laboratories, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BUSS03
- 2R44AG017400