New Tools for Assessing Fracture Risk

Not Applicable

Terminated

• Conditions: Osteoporosis; Fracture Risk Assessment
• Interventions: Device: Osteoprobe-Reference Point Indentation (RPI); Radiation: Dual-energy X-ray absorptiometry (DXA) Scans; Radiation: MRI

• Registration Number: NCT02436356
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-05-01
• Study First Posted: 2015-05-06
• Study Start: 2015-06-30
• Primary Completion: 2018-05-23
• Study Completion: 2018-11-08
• Disposition First Submitted: 2020-05-04
• Disposition First Submitted QC: 2020-05-14
• Disposition First Posted: 2020-05-19
• Results First Submitted: 2020-06-29
• Results First Submitted QC: 2020-09-17
• Status Verified: 2020-10
• Results First Posted: 2020-10-12
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distal Radius Fracture Operative Group	Osteoprobe-Reference Point Indentation (RPI)	Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Distal Radius Fracture Operative Group	Dual-energy X-ray absorptiometry (DXA) Scans	Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
Distal Radius Fracture Non-operative Group	Dual-energy X-ray absorptiometry (DXA) Scans	Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.
Healthy Volunteers (Non Fracture Group)	MRI	Healthy volunteers will undergo DXA and MRI scans.
Healthy Volunteers (Non Fracture Group)	Dual-energy X-ray absorptiometry (DXA) Scans	Healthy volunteers will undergo DXA and MRI scans.
Distal Radius Fracture Non-operative Group	MRI	Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.
Distal Radius Fracture Operative Group	MRI	Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.

Primary Outcome Measures

Name	Time	Method
MRI Scan Measurements	Within a week before or after surgery to repair distal radius fracture	Pore Water Fraction
Osteoprobe Measurements	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	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 Outcome Measures

Name	Time	Method
Patient-reported Measurements	Baseline and Post-op/-treatment: 3, 6, and 12 weeks	PRWE (Patient-rated wrist evaluation) is a 15-item survey designed to measure wrist pain and disability in activities of daily living. The PRWE consists of a pain subscale and a function subscale. The pain subscale contains 5 items, each rated 0 (no pain) to 10 (worst pain ever). The pain subscale is calculated by adding all 5 item scores together (minimum score: 0, maximum score: 50). A lower score indicates a lower pain level. The function subscale contains 10 items, each rated 0 (no difficulty) to 10 (unable to do). The function subscale is calculated by adding all 10 item scores together and dividing by 2 (minimum score: 0, maximum score: 100). A lower score indicates a lower disability level. The total PRWE score is calculated by adding the pain and function subscales together. The total PRWE score ranges from 0 (best score) to 100 (worst score). The lower the score the better the outcome.

Trial Locations

Locations (1)

Vanderbilt Univeristy Medical Center; 🇺🇸 Nashville, Tennessee, United States