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Bone UltraSonic Scanner (BUSS) Clinical Optimization Study (BUSS)

This study has been completed.
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Artann Laboratories Identifier:
First received: January 24, 2010
Last updated: March 28, 2014
Last verified: March 2014
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.


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment

Resource links provided by NLM:

Further study details as provided by Artann Laboratories:

Primary Outcome Measures:
  • To obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions. [ Time Frame: 6 months ]

Enrollment: 100
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study participants will consist of groups with no history of osteoporosis, established osteoporosis and may include documented history of fracture.

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01056432

United States, Pennsylvania
Health Smart Medical Center
Philadelphia, Pennsylvania, United States, 19115
Sponsors and Collaborators
Artann Laboratories
National Institute on Aging (NIA)
Principal Investigator: Armen Sarvazyan, Ph.D., D.Sc. Artann Laboratories
  More Information

Responsible Party: Artann Laboratories Identifier: NCT01056432     History of Changes
Other Study ID Numbers: BUSS-02
2R44AG017400 ( US NIH Grant/Contract Award Number )
Study First Received: January 24, 2010
Last Updated: March 28, 2014

Keywords provided by Artann Laboratories:
osteoporosis, bone fracture risk, bone ultrasonometry

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases processed this record on April 27, 2017