Status:
COMPLETED
Bone UltraSonic Scanner (BUSS): Validation Study
Lead Sponsor:
Artann Laboratories
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Osteoporosis
Osteopenia
Eligibility:
FEMALE
50-90 years
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 osteoporosi...
Eligibility Criteria
Inclusion
- Postmenopausal
- Age 50-90 years
- Any race or ethnicity
- DXA spine and hip exam within one year
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01439139
Start Date
September 1 2011
End Date
May 1 2013
Last Update
March 28 2014
Active Locations (1)
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1
Catholic Health System Affiliates & Sister's of Charity Hospital
Buffalo, New York, United States, 14220