Bone UltraSonic Scanner (BUSS): Validation Study

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Institute on Aging (NIA)

Information provided by (Responsible Party):

Artann Laboratories

ClinicalTrials.gov Identifier:

NCT01439139

First received: September 21, 2011

Last updated: October 11, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 21, 2011

Last Updated Date

October 11, 2012

Start Date ^ICMJE

September 2011

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01439139 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bone UltraSonic Scanner (BUSS): Validation Study

Official Title ^ICMJE

Portable Bone Ultrasonometer for Osteoporosis Assessment

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

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

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Postmenopausal women

Condition ^ICMJE

Osteoporosis
Osteopenia

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2012

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

50 Years to 90 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01439139

Other Study ID Numbers ^ICMJE

BUSS-04, 2R44AG017400

Has Data Monitoring Committee

Responsible Party

Artann Laboratories

Study Sponsor ^ICMJE

Artann Laboratories

Collaborators ^ICMJE

National Institute on Aging (NIA)

Investigators ^ICMJE

Study Chair:

Armen Sarvazyan, Ph.D., D.Sc.

Artann Laboratories, Inc

Information Provided By

Artann Laboratories

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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