Bone UltraSonic Scanner (BUSS) Clinical Optimization Study

Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01056432

Acronym

BUSS

Enrollment

100

Registered

2010-01-26

Start date

2010-01-31

Completion date

2011-01-31

Last updated

2014-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

osteoporosis, bone fracture risk, bone ultrasonometry

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 90 Years

Healthy volunteers

Yes

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 \-

Design outcomes

Primary

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

Countries

United States

Outcome results