NCT01439139
Completed
Not Applicable
Portable Bone Ultrasonometer for Osteoporosis Assessment
Artann Laboratories1 site in 1 country130 target enrollmentStarted: September 2011Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Artann Laboratories
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.
Overview
Brief Summary
The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection.
Detailed Description
Study will conduct measurements in a group of postmenopausal women and use their DXA examination data as a control. BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Postmenopausal
- •Age 50-90 years
- •Any race or ethnicity
- •DXA spine and hip exam within one year
Exclusion Criteria
- •Open wounds or rashes on the testing area
- •Active skin infection
- •Recent tibia surgery
- •Abnormal tibia anatomy
- •Body Mass Index \> 34.9 kg/m2
- •Current or previous tibial fracture on side of testing
- •Stroke or 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:
- •Bisphosphonates
- •Calcitonin
Outcomes
Primary Outcomes
BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk AssessmentOsteoporosisFractureAgingNCT01123421Artann Laboratories113
Completed
Not Applicable
Bone UltraSonic Scanner (BUSS) Clinical Optimization StudyOsteoporosisNCT01056432Artann Laboratories100
Terminated
Not Applicable
Bindex Ultrasonometer for Osteoporosis DiagnosticsOsteoporosisNCT01935232Bone Index Finland Ltd135
Completed
Not Applicable
Cortical Bone Assessment Using Ultrasonic Guided Waves: Towards a Robust Clinical MeasurementOsteoporotic FracturesNCT05424536Universidad de Valparaiso50
Completed
Not Applicable
Age Dependend Diagnostic Thresholds for Osteoporosis Bindex UltrasonometerOsteoporosisNCT01978834Bone Index Finland Ltd560