New Tools for Assessing Fracture Risk
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoporosis
- Sponsor
- Vanderbilt University Medical Center
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- MRI Scan Measurements
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Jeffry Nyman
Assistant Professor of Orthopaedics and Rehabilitation
Vanderbilt University Medical Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
MRI Scan Measurements
Time Frame: Within a week before or after surgery to repair distal radius fracture
Pore Water Fraction
Osteoprobe Measurements
Time Frame: Within a week before or after surgery to repair distal radius fracture
Bone Material Strength index (BMSi) By engaging the bone at 10 N and then delivering a single impact force of \~40 N, the OsteoProbe records the maximum penetration depth of conical-spherical tip into cortical bone. This indentation distance increase (IDI) is indexed to the IDI acquired from a reference material immediately after the bone IDI measurements, such that the OsteoProbe-based measurement known as bone material strength index (BMSi) is 100 times IDI of reference material divided by IDI of the patient's bone. A lower BMSi measurement is the result of a higher indentation distance into the bone. For statistical analysis, we used the mean of the 10 BMSi measurements per case.
DXA Scan Measurements
Time Frame: Within a week before or after surgery to repair distal radius fracture
A T-score is the number of standard deviations (SD) below (negative value) or above (positive value) the mean BMD (bone mineral density) for a healthy population. A person with T-score below -2.5 is considered to have osteoporosis.
Secondary Outcomes
- Patient-reported Measurements(Baseline and Post-op/-treatment: 3, 6, and 12 weeks)