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NCT01123421 Clinical Trial

Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment

Aging Clinical Trial

— BUSS03  

Official title:
Portable Ultrasonometer for Osteoporosis Assessment: Retrospective Fracture Risk Validation Study, Version #1

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01123421
Other study ID # BUSS03
Secondary ID 2R44AG017400
Status Completed
Phase N/A
First received May 12, 2010
Last updated October 11, 2012
Start date May 2010
Est. completion date February 2012

Study information
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

Clinical Trial 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.

Description:

One of several studies to develop and clinically validate a novel ultrasonographic device, BUSS, for the assessment of osteoporosis and fracture risk.

Recruitment information / eligibility
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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (4)
Lead Sponsor Collaborator
Artann Laboratories Mayo Clinic, National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
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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