Bone UltraSonic Scanner (BUSS): Validation Study | NCT01439139

Studies
Bone UltraSonic Scanner (BUSS): Validation Study

NCT01439139

Sponsor

Artann Laboratories

Status

Completed

Last Update Posted

Mar 28, 2014Estimated

Enrollment

130Actual

Phase

Not provided

Conditions

Osteoporosis
Osteopenia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2R44AG017400	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Sep 21, 2011

First Submission Date that Met QC Criteria

Sep 22, 2011

First Posted Date

Sep 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2014

Last Update Posted Date

Mar 28, 2014Estimated

Name	Class
National Institute on Aging (NIA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Postmenopausal women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armen Sarvazyan, Ph.D., D.Sc.	Artann Laboratories, Inc	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catholic Health System Affiliates & Sister's of Charity Hospital		Buffalo	New York	14220	United States

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D001851	Bone Diseases, Metabolic

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided