Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment

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.

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Key information

Conditions

Osteoporosis Aging Bone Diseases Bone Diseases, Metabolic Fracture Fractures, Bone Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Wounds and Injuries

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Artann Laboratories

Industry

Collaborators

Mayo Clinic
National Institute on Aging (NIA)
National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: BUSS03

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: May 14, 2010
Registry last updated: Oct 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed