Bone UltraSonic Scanner (BUSS): Validation Study

Portable Bone Ultrasonometer for Osteoporosis Assessment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01439139

Enrollment

130

Registered

2011-09-23

Start date

2011-09-30

Completion date

2013-05-31

Last updated

2014-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia, Osteoporosis

Keywords

Osteoporosis, ultrasound, sonometer, DXA

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.	1 year

Countries

United States

Outcome results