NCT02436356

New Tools for Assessing Fracture Risk

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

• Osteoporosis
• Fracture Risk Assessment

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-06-30
• Primary completion: 2018-05-23
• Completion: 2018-11-08
• First posted: 2015-05-06
• Last updated: 2020-11-02
• Results posted: 2020-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study