Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment (BUSS03)

October 11, 2012 updated by: Artann Laboratories

Portable Ultrasonometer for Osteoporosis Assessment: Retrospective Fracture Risk Validation Study, Version #1

Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of osteoporosis and predict prevalent osteoporotic fractures. Measurements derived from the BUSS parameters will be able to discriminate between postmenopausal women with osteoporotic fractures when compared to matched controls without history of osteoporotic fracture.

Study Overview

Status

Completed

Conditions

Detailed Description

One of several studies to develop and clinically validate a novel ultrasonographic device, BUSS, for the assessment of osteoporosis and fracture risk.

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Both groups

Description

Inclusion Criteria:

  • postmenopausal women with osteoporotic fracture at spine or wrist
  • postmenopausal women no history of fracture at spine or wrist

Exclusion Criteria:

  • women with a history of metabolic disease
  • stroke
  • tibia fracture or surgery
  • BMI ≥ 35 kg/m2
  • Teriparatide use currently or within the past 6 months,
  • Any skin issues (open wounds or rashes, and/or skin infections) of the tibial area.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
With osteoporotic fracture
Approximately 100 postmenopausal women that have been enrolled in a population-based case-control study that have experienced a clinically-diagnosed fracture of thoracolumbar spine or distal forearm due to minimal or moderate trauma based on review on their inpatient and outpatient medical records will be enrolled.
Without osteoporotic fracture
Approximately 100 control women will have no history of a prior spine, hip, or wrist fracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artann Laboratories

Collaborators

Mayo Clinic
National Institutes of Health (NIH)
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Armen Sarvazyan, Ph.D., D.Sc., Artann Laboratories, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

May 12, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (Estimate)

May 14, 2010

Study Record Updates

Last Update Posted (Estimate)

October 15, 2012

Last Update Submitted That Met QC Criteria

October 11, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUSS03
  • 2R44AG017400 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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