Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment

Overview

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.

Full Title of Study: “Portable Ultrasonometer for Osteoporosis Assessment: Retrospective Fracture Risk Validation Study, Version #1”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: April 2011

Detailed Description

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

Arms, Groups and 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Artann Laboratories
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Armen Sarvazyan, Ph.D., D.Sc., Principal Investigator, Artann Laboratories, Inc.

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