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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Mayo Clinic
Information provided by (Responsible Party):
Artann Laboratories
ClinicalTrials.gov Identifier:
NCT01123421
First received: May 12, 2010
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition
Osteoporosis
Fracture
Aging

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Portable Ultrasonometer for Osteoporosis Assessment: Retrospective Fracture Risk Validation Study, Version #1

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Artann Laboratories:

Primary Outcome Measures:
  • Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood


Enrollment: 113
Study Start Date: May 2010
Study Completion Date: February 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Both groups

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123421

Locations
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Artann Laboratories
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Mayo Clinic
Investigators
Principal Investigator: Armen Sarvazyan, Ph.D., D.Sc. Artann Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT01123421     History of Changes
Other Study ID Numbers: BUSS03, 2R44AG017400
Study First Received: May 12, 2010
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Artann Laboratories:
osteoporosis
fracture risk
aging
tibia
sonometer
ultrasound
 BMD
bone mineral density
DXA
3D-HRpQT
waveform profiles

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Osteoporotic Fractures
Wounds and Injuries
 Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 22, 2013