Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment

Completed

• Conditions: Osteoporosis; Fracture; Aging

• Registration Number: NCT01123421
• Lead Sponsor: Artann Laboratories

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-14
• Primary Completion: 2011-04
• Study Completion: 2012-02
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-11
• Last Update Posted: 2012-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 113

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States