Bone UltraSonic Scanner (BUSS): Validation Study

Artann Laboratories

Status: Completed

Conditions: Osteopenia; Osteoporosis

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT01439139

BUSS-04

2R44AG017400 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 patients

Sex: Female

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

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