Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment (BUSS03)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||Portable Ultrasonometer for Osteoporosis Assessment: Retrospective Fracture Risk Validation Study, Version #1|
- Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||May 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
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.
Without osteoporotic fracture
Approximately 100 control women will have no history of a prior spine, hip, or wrist fracture.
One of several studies to develop and clinically validate a novel ultrasonographic device, BUSS, for the assessment of osteoporosis and fracture risk.
|United States, Minnesota|
|Mayo Clinic Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Armen Sarvazyan, Ph.D., D.Sc.||Artann Laboratories, Inc.|