Bone UltraSonic Scanner (BUSS): Validation Study

Osteoporosis Clinical Trial

Official title:

Portable Bone Ultrasonometer for Osteoporosis Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439139
• Other study ID #: BUSS-04
• Secondary ID: 2R44AG017400
• Status: Completed
• Phase: N/A
• First received: September 21, 2011
• Last updated: March 27, 2014
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: March 2014
• Source: Artann Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

Locations

Country	Name	City	State
United States	Catholic Health System Affiliates & Sister's of Charity Hospital	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Artann Laboratories	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

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