Bone UltraSonic Scanner (BUSS) Clinical Optimization Study

Completed

• Conditions: Osteoporosis

• Registration Number: NCT01056432
• Lead Sponsor: Artann Laboratories

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-24
• Study First Submitted QC: 2010-01-24
• Study First Posted: 2010-01-26
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-28
• Last Update Posted: 2014-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.	6 months

Trial Locations

Locations (1)

Health Smart Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States