Bone UltraSonic Scanner (BUSS) Clinical Optimization Study

Osteoporosis Clinical Trial

— BUSS  

Official title:

Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056432
• Other study ID #: BUSS-02
• Secondary ID: 2R44AG017400
• Status: Completed
• Phase: N/A
• First received: January 24, 2010
• Last updated: March 28, 2014
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: March 2014
• Source: Artann Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Osteoporosis

Locations

Country	Name	City	State
United States	Health Smart Medical Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Artann Laboratories	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.		6 months	No