Osteoporosis Clinical Trial
Official title:
Portable Bone Ultrasonometer for Osteoporosis Assessment
Verified date | March 2014 |
Source | Artann Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection.
Status | Completed |
Enrollment | 130 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 90 Years |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Catholic Health System Affiliates & Sister's of Charity Hospital | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Artann Laboratories | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements. | 1 year | No |
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