Bone UltraSonic Scanner (BUSS) Clinical Optimization Study

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-01-31

Brief Summary

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The aim of this clinical study using Bone UltraSonic Scanner (BUSS) is to obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.

Detailed Description

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The specific aims of this clinical study are:

1. To optimize the data collection technique and establish an examination procedure;
2. To collect data necessary for assessing the performance of BUSS sensors;
3. To evaluate the probe ergonomic design and participant tolerance to probe application;
4. To assess the clinical suitability of the software interface in data collection;
5. To adjust the BUSS diagnostic algorithms using dual-energy X-ray absorptiometry (DEXA) data as a "gold" standard in osteoporosis detection and characterization;
6. To evaluate BUSS performance including ease of use and consistency.

Conditions

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Osteoporosis

Keywords

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osteoporosis, bone fracture risk, bone ultrasonometry

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Any race or ethnical group DEXA examination scheduled within next two weeks or DEXA examination was completed within the last six months adn DEXA results are available

Exclusion Criteria

Open wounds or rashes on the tibial testing area Active skin infection Recent tibia surgery Abnormal tibia Anatomy Current or previous tibial fracture Body Mass Index \>34.9 Hyperparathyroidism or hypoparathyroidism within 5 years Osteitis deformans Renal osteodystrophy Osteomalacia Stroke with total or partial paralysis with residual disability lasting more than 3 months Current or recent (within past 6 months) use of bone-active drugs Drugs under research protocols Chronic use of over the counter antacids

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Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Locations

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Health Smart Medical Center

Philadelphia, Pennsylvania, 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

BUSS-02

Identifier Type: -

Identifier Source: org_study_id