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Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01123421
Acronym
BUSS03
Enrollment
113
Registered
2010-05-14
Start date
2010-05-31
Completion date
2012-02-29
Last updated
2012-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Fracture, Osteoporosis

Keywords

osteoporosis, fracture risk, aging, tibia, sonometer, ultrasound, BMD, bone mineral density, DXA, 3D-HRpQT, waveform profiles

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.

Detailed description

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

Interventions

None listed

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute on Aging (NIA)
CollaboratorNIH
Mayo Clinic
CollaboratorOTHER
Artann Laboratories
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women.1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026