Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-02-29

Brief Summary

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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

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

Conditions

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Osteoporosis Fracture Aging

Keywords

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Without osteoporotic fracture

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

No interventions assigned to this group

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Armen Sarvazyan, Ph.D., D.Sc.

Role: PRINCIPAL_INVESTIGATOR

Artann Laboratories, Inc.

Locations

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Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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2R44AG017400

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BUSS03

Identifier Type: -

Identifier Source: org_study_id