Bone UltraSonic Scanner (BUSS): Validation Study
Completed
- Conditions
- OsteoporosisOsteopenia
- Registration Number
- NCT01439139
- Lead Sponsor
- Artann Laboratories
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 130
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
- Estrogens or selective estrogen receptor modulator (SERM)
- Therapeutic doses of fluoride (> 2mg/day)
- Teriparatide used currently or within past 3 months
- Drugs under research protocols, and
- Unstudied or unapproved drugs
- Presence of metabolic bone disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements. 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Catholic Health System Affiliates & Sister's of Charity Hospital
🇺🇸Buffalo, New York, United States