Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment (BUSS03)

Artann Laboratories

Status: Completed

Conditions: Osteoporosis; Aging; Fracture

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT01123421

BUSS03

2R44AG017400 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 113 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

113 participants in 2 patient groups

With osteoporotic fracture

Description:

Approximately 100 postmenopausal women that have been enrolled in a population-based case-control study that have experienced a clinically-diagnosed fracture of thoracolumbar spine or distal forearm due to minimal or moderate trauma based on review on their inpatient and outpatient medical records will be enrolled.

Without osteoporotic fracture

Description:

Approximately 100 control women will have no history of a prior spine, hip, or wrist fracture.