Bone UltraSonic Scanner (BUSS): Validation Study

Artann Laboratories130 enrolled

Overview

The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection.

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 Type

OBSERVATIONAL

Enrollment

130

Conditions

Osteoporosis Osteopenia

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Catholic Health System Affiliates & Sister's of Charity Hospital

Buffalo, New York, United States

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

Data from ClinicalTrials.gov

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