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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056432
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : March 31, 2014
National Institute on Aging (NIA)
Information provided by (Responsible Party):
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.

Condition or disease

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment
Study Start Date : January 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056432

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United States, Pennsylvania
Health Smart Medical Center
Philadelphia, Pennsylvania, United States, 19115
Sponsors and Collaborators
Artann Laboratories
National Institute on Aging (NIA)
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Principal Investigator: Armen Sarvazyan, Ph.D., D.Sc. Artann Laboratories
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Responsible Party: Artann Laboratories Identifier: NCT01056432    
Other Study ID Numbers: BUSS-02
2R44AG017400 ( U.S. NIH Grant/Contract )
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014
Keywords provided by Artann Laboratories:
osteoporosis, bone fracture risk, bone ultrasonometry
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases