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ACTIVE NOT RECRUITING
NCT03076034
NA

Utility of Cortical Bone Tissue Properties in the Assessment of Fracture Risk

Sponsor: Beth Israel Deaconess Medical Center

View on ClinicalTrials.gov

Summary

The objective of this study is to determine whether a new minimally invasive method for in vivo measurement of cortical bone tissue properties can identify those who are at risk for fragility fractures of the hip and radius. The investigators hypothesis is that women with fragility fractures of the hip and radius have altered cortical bone tissue properties compared to non-fracture controls independent of standard clinical tests, such as bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA).

Key Details

Gender

All

Age Range

50 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2015-01-26

Completion Date

2028-11

Last Updated

2025-10-28

Healthy Volunteers

Yes

Interventions

DEVICE

Reference Point Indentation

The "Osteoprobe": Since these first reports of indentation measurements in humans in vivo, a more 'user-friendly' device, the Osteoprobe® has been developed by Active Life Scientific (Santa Barbara, CA) (10). The Osteoprobe®, which we will use in the current study, is smaller than the previous reference point indentation (RPI) instrument and is designed to be used in a hand-held fashion to allow for rapid measurements. The new instrument does not require a reference probe, because the inertia of the instrument keeps it adequately fixed in space during the short time of the indentation impact (\~0.25 milliseconds). The main parameter measured is the distance that the probe further indents into the bone from the reference point. Key components of the Osteoprobe® include an impact generation mechanism, a displacement transducer, and a probe made of hardened stainless steel with a 90 degree conical tip, with a tip diameter of \~375 µm.

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States