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New Tools for Assessing Fracture Risk

NCT02436356 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-11-02

Study results available
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Summary

The goal of this study is to determine whether two new, non-X-ray techniques can discriminate between high-energy fractures of normal bone (trauma) and low-energy fractures (fragility) of osteoporotic bone. The current gold-standard for assessing fracture risk areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA) is not particularly effective at identifying individuals who are at risk of suffering a fracture. Yet, there is a growing population of diabetics and elderly individuals prone to fractures. In effect, the age-related and diabetes-related increase in fracture risk is independent of a person's aBMD. These findings stress the urgency in developing diagnostic tools that can improve fracture risk prediction so that patients can be treated with the appropriate anti-fracture therapies.

Conditions

Interventions

DEVICE

Osteoprobe-Reference Point Indentation (RPI)

Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).

RADIATION

Dual-energy X-ray absorptiometry (DXA) Scans

Assessment of Fracture Risk

RADIATION

MRI

Determines bound water and pore water of bone.

Sponsors & Collaborators

  • ActiveLife Scientific

    collaborator INDUSTRY

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Jeffry S Nyman, PhD · Vanderbilt University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-05-23
Completion
2018-11-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02436356 on ClinicalTrials.gov