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New Tools for Assessing Fracture Risk

Primary Purpose

Osteoporosis, Fracture Risk Assessment

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Osteoprobe-Reference Point Indentation (RPI)

Dual-energy X-ray absorptiometry (DXA) Scans

MRI

About this trial

This is an interventional diagnostic trial for Osteoporosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion/exclusion criteria for patients with a high-energy or fragility fracture requiring operative fixation (Arm 1)

Number of patients in Arm#1= 60 patients

Inclusion criteria:

Patients who are 18 years of age or older. This age range accounts for 60% of all distal radius fractures seen at Vanderbilt University Medical Center.
Patients who have sustained a low or high energy distal radius fracture that involves the metaphysis and requires open reduction internal fixation using volar plating.
English speaking due to feasibility of employing study personnel to deliver and assess study intervention.

Exclusion criteria:

Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years
Patients who have Type 1 diabetes
Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)
Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use
Patients that would not be able to have a DXA scan (weight >350lbs, hardware in hips, patients that have lap band device)
Patients who are pregnant or who think they may be pregnant
Patients that have a medical contraindication to MRI (if patients are undergoing a study MRI)
Patients who have concurrent, bilateral upper extremity fractures where hardware or casting may affect study scan measurements
Patients who have distal radial shaft fractures

Exclusion criteria 1-5 are included because the goal of the study is to demonstrate whether new bone measurements differentiate normal bone from fragile bone. These exclusion criteria eliminate confounding factors that affect fracture resistance of bone in ways that are independent of osteoporosis. Exclusion criteria 6-8 are practical since DXA/MRI scans cannot accommodate all people.

Inclusion/exclusion criteria for patients with no fracture (Arm 2)

Number of patients in Arm#2= 40 patients

Inclusion criteria:

Patients who are 18 years of age or older.
Patients who have no history of fracture or family history of pathologic fracture
English speaking due to feasibility of employing study personnel to deliver and assess study intervention.

Exclusion criteria:

Patients who are taking medication to treat osteoporosis (e.g. bisphosphonate)
Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years
Patients who have Type 1 diabetes
Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism).
Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use.
Patients that would not be able to have a DXA scan (weight >350lbs, hardware in hips, patients that have lap band device)
Patients who are pregnant or who think they may be pregnant.
Patients that have a medical contraindication to MRI.

Exclusion criteria 1-5 are included because the goal of the study is to demonstrate whether new bone measurements differentiate normal bone from fragile bone. These exclusion criteria eliminate confounding factors that affect fracture resistance of bone in ways that are independent of osteoporosis. Exclusion criteria 6- 8 are practical since DXA/MRI scans cannot accommodate all people.

Inclusion/exclusion criteria for patients with a high-energy or fragility fracture requiring nonoperative treatment (Arm 3)

Number of patients in Arm#3= up to 10 patients

Inclusion criteria:

Patients who are 18 years of age or older. This age range accounts for 60% of all distal radius fractures seen at Vanderbilt University Medical Center.
Patients who have sustained a low or high energy distal radius fracture that requires nonoperative treatment
English speaking due to feasibility of employing study personnel to deliver and assess study intervention.

Exclusion criteria:

Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years
Patients who have Type 1 diabetes
Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)
Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use
Patients that would not be able to have a DXA scan (weight >350lbs, hardware in hips, patients that have lap band device)
Patients who are pregnant or who think they may be pregnant
Patients that have a medical contraindication to MRI (if patients are undergoing a study MRI)
Patients who have concurrent, bilateral upper extremity fractures where hardware or casting may affect study scan measurements

Sites / Locations

Vanderbilt Univeristy Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Distal Radius Fracture Operative Group

Healthy Volunteers (Non Fracture Group)

Distal Radius Fracture Non-operative Group

Arm Description

Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.

Healthy volunteers will undergo DXA and MRI scans.

Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.

Outcomes

Primary Outcome Measures

Osteoprobe Measurements

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.

MRI Scan Measurements

Bound Water Fraction

MRI Scan Measurements

Pore Water Fraction

DXA Scan Measurements

Bone Mineral Density

DXA Scan Measurements

Bone Mineral Content

DXA Scan Measurements

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

Patient-reported Measurements

DASH (Disabilities of the Arm, Shoulder, and Hand) is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limbs. The score ranges from 0 (no disability) to 100 (most severe disability). A higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability.

Patient-reported Measurements

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.

Full Information

NCT ID

NCT02436356

First Posted

April 24, 2015

Last Updated

October 12, 2020

Sponsor

Vanderbilt University Medical Center

Collaborators

ActiveLife Scientific, National Center for Advancing Translational Sciences (NCATS)

1. Study Identification

Unique Protocol Identification Number

NCT02436356

Brief Title

New Tools for Assessing Fracture Risk

Official Title

New Tools for Assessing Fracture Risk

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Terminated

Why Stopped

FDA determined study device is significant risk. Study will not seek IDE.

Study Start Date

June 30, 2015 (Actual)

Primary Completion Date

May 23, 2018 (Actual)

Study Completion Date

November 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

Collaborators

ActiveLife Scientific, National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Fracture Risk Assessment

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Distal Radius Fracture Operative Group

Arm Type

Active Comparator

Arm Description

Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.

Arm Title

Healthy Volunteers (Non Fracture Group)

Arm Type

Active Comparator

Arm Description

Healthy volunteers will undergo DXA and MRI scans.

Arm Title

Distal Radius Fracture Non-operative Group

Arm Type

Active Comparator

Arm Description

Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.

Intervention Type

Device

Intervention Name(s)

Osteoprobe-Reference Point Indentation (RPI)

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Dual-energy X-ray absorptiometry (DXA) Scans

Intervention Description

Assessment of Fracture Risk

Intervention Type

Radiation

Intervention Name(s)

MRI

Intervention Description

Determines bound water and pore water of bone.

Primary Outcome Measure Information:

Title

Osteoprobe Measurements

Description

Time Frame