New Tools for Assessing Fracture Risk

October 12, 2020 updated by: Jeffry Nyman, Vanderbilt University Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Univeristy Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

  1. 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.
  2. 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.
  3. English speaking due to feasibility of employing study personnel to deliver and assess study intervention.

Exclusion criteria:

  1. Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
  2. Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years
  3. Patients who have Type 1 diabetes
  4. Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)
  5. Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use
  6. Patients that would not be able to have a DXA scan (weight >350lbs, hardware in hips, patients that have lap band device)
  7. Patients who are pregnant or who think they may be pregnant
  8. Patients that have a medical contraindication to MRI (if patients are undergoing a study MRI)
  9. Patients who have concurrent, bilateral upper extremity fractures where hardware or casting may affect study scan measurements
  10. 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:

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

Exclusion criteria:

  1. Patients who are taking medication to treat osteoporosis (e.g. bisphosphonate)
  2. Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years
  3. Patients who have Type 1 diabetes
  4. Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism).
  5. Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use.
  6. Patients that would not be able to have a DXA scan (weight >350lbs, hardware in hips, patients that have lap band device)
  7. Patients who are pregnant or who think they may be pregnant.
  8. 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:

  1. 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.
  2. Patients who have sustained a low or high energy distal radius fracture that requires nonoperative treatment
  3. English speaking due to feasibility of employing study personnel to deliver and assess study intervention.

Exclusion criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Distal Radius Fracture Operative Group
Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.
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.
Active Comparator: Healthy Volunteers (Non Fracture Group)
Healthy volunteers will undergo DXA and MRI scans.
Radiation: Dual-energy X-ray absorptiometry (DXA) Scans
Assessment of Fracture Risk
Radiation: MRI
Determines bound water and pore water of bone.
Active Comparator: Distal Radius Fracture Non-operative Group
Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.
Radiation: Dual-energy X-ray absorptiometry (DXA) Scans
Assessment of Fracture Risk
Radiation: MRI
Determines bound water and pore water of bone.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within a week before or after surgery to repair distal radius fracture
MRI Scan Measurements
Time Frame: Within a week before or after surgery to repair distal radius fracture
Bound Water Fraction
Within a week before or after surgery to repair distal radius fracture
MRI Scan Measurements
Time Frame: Within a week before or after surgery to repair distal radius fracture
Pore Water Fraction
Within a week before or after surgery to repair distal radius fracture
DXA Scan Measurements
Time Frame: Within a week before or after surgery to repair distal radius fracture
Bone Mineral Density
Within a week before or after surgery to repair distal radius fracture
DXA Scan Measurements
Time Frame: Within a week before or after surgery to repair distal radius fracture
Bone Mineral Content
Within a week before or after surgery to repair distal radius fracture
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.
Within a week before or after surgery to repair distal radius fracture

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-reported Measurements
Time Frame: Baseline/One-Time Completion and Post-op/-treatment: 3, 6, and 12 weeks
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.
Baseline/One-Time Completion and Post-op/-treatment: 3, 6, and 12 weeks
Patient-reported Measurements
Time Frame: 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.
Baseline and Post-op/-treatment: 3, 6, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Advancing Translational Sciences (NCATS)
ActiveLife Scientific

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffry S Nyman, PhD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 23, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 8, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 141125
  • UL1TR000445 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plant to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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