Aging Clinical Trial
— BUSS03Official title:
Portable Ultrasonometer for Osteoporosis Assessment: Retrospective Fracture Risk Validation Study, Version #1
Verified date | October 2012 |
Source | Artann Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 113 |
Est. completion date | February 2012 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - postmenopausal women with osteoporotic fracture at spine or wrist - postmenopausal women no history of fracture at spine or wrist Exclusion Criteria: - women with a history of metabolic disease - stroke - tibia fracture or surgery - BMI = 35 kg/m2 - Teriparatide use currently or within the past 6 months, - Any skin issues (open wounds or rashes, and/or skin infections) of the tibial area. |
Observational Model: Case Control, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Artann Laboratories | Mayo Clinic, National Institute on Aging (NIA), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women. | 1 year | No |
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