Bone UltraSonic Scanner (BUSS) Clinical Optimization Study
This study has been completed.
Information provided by (Responsible Party):
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.
||Observational Model: Case-Only
Time Perspective: Retrospective
||Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment
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 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2011 (Final data collection date for primary outcome measure)
The specific aims of this clinical study are:
- To optimize the data collection technique and establish an examination procedure;
- To collect data necessary for assessing the performance of BUSS sensors;
- To evaluate the probe ergonomic design and participant tolerance to probe application;
- To assess the clinical suitability of the software interface in data collection;
- To adjust the BUSS diagnostic algorithms using dual-energy X-ray absorptiometry (DEXA) data as a "gold" standard in osteoporosis detection and characterization;
- To evaluate BUSS performance including ease of use and consistency.
|Ages Eligible for Study:
||21 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Study participants will consist of groups with no history of osteoporosis, established osteoporosis and may include documented history of fracture.
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
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01056432
|Health Smart Medical Center
|Philadelphia, Pennsylvania, United States, 19115 |
||Armen Sarvazyan, Ph.D., D.Sc.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 24, 2010
||March 28, 2014
||United States: Institutional Review Board
Keywords provided by Artann Laboratories:
osteoporosis, bone fracture risk, bone ultrasonometry
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 23, 2014
Bone Diseases, Metabolic