BUSS03: Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Fracture Aging

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 Design

Study Type:

Observational

Actual Enrollment :

113 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
With osteoporotic fracture 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 Approximately 100 control women will have no history of a prior spine, hip, or wrist fracture.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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.