Skip to content

New Tools for Assessing Fracture Risk

New Tools for Assessing Fracture Risk

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02436356
Enrollment
48
Registered
2015-05-06
Start date
2015-06-30
Completion date
2018-11-08
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture Risk Assessment, Osteoporosis

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.

Interventions

DEVICEOsteoprobe-Reference Point Indentation (RPI)

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

RADIATIONDual-energy X-ray absorptiometry (DXA) Scans

Assessment of Fracture Risk

RADIATIONMRI

Determines bound water and pore water of bone.

Sponsors

ActiveLife Scientific
CollaboratorINDUSTRY
National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Osteoprobe MeasurementsWithin a week before or after surgery to repair distal radius fractureBone 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 MeasurementsWithin a week before or after surgery to repair distal radius fractureBound Water Fraction
DXA Scan MeasurementsWithin a week before or after surgery to repair distal radius fractureBone Mineral Density

Secondary

MeasureTime frameDescription
Patient-reported MeasurementsBaseline/One-Time Completion and Post-op/-treatment: 3, 6, and 12 weeksDASH (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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Distal Radius Fracture Operative Group
Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation. Osteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength). Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk MRI: Determines bound water and pore water of bone.
28
Healthy Volunteers (Non Fracture Group)
Healthy volunteers will undergo DXA and MRI scans. Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk MRI: Determines bound water and pore water of bone.
10
Distal Radius Fracture Non-operative Group
Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation. Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk MRI: Determines bound water and pore water of bone.
2
Total40

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyExcluded by MRI Screening002
Overall StudyExcluded due to other medical conditions300
Overall StudyLost to Follow-up010
Overall StudySurgical Approach (Dorsal not volar)100
Overall StudyWithdrawal by Subject100

Baseline characteristics

CharacteristicDistal Radius Fracture Operative GroupHealthy Volunteers (Non Fracture Group)Distal Radius Fracture Non-operative GroupTotal
Age, Continuous47 years44 years30 years40 years
Body Mass Index (BMI)27.9 kg/m227.55 kg/m225.61 kg/m227.7 kg/m2
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
26 Participants9 Participants2 Participants37 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants0 Participants0 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
25 Participants10 Participants2 Participants37 Participants
Region of Enrollment
United States
28 participants10 participants2 participants40 participants
Sex: Female, Male
Female
19 Participants7 Participants0 Participants26 Participants
Sex: Female, Male
Male
9 Participants3 Participants2 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 100 / 2
other
Total, other adverse events
0 / 280 / 100 / 2
serious
Total, serious adverse events
0 / 280 / 100 / 2

Outcome results

Primary

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.

Time frame: Within a week before or after surgery to repair distal radius fracture

Population: Distal Radius Fracture Operative Group- Includes 7 high energy fracture and 14 low energy fracture subjects.~High Energy: 1 did not have L1-L4 scanned, 2 did not receive calculations due to age. Low Energy- 3 did not have a DXA scan.~Healthy Volunteers- 1 subject did not have a DXA scan.

ArmMeasureGroupValue (MEDIAN)
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- L1-L4 VB0.8 t-score
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- L1-L4 VB0.6 t-score
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- Hip1.2 t-score
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- Hip-0.2 t-score
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- Femur neck0.7 t-score
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- Femur neck-0.4 t-score
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- Radius distal-third0.7 t-score
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- Radius distal-third0.8 t-score
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- Radius ultra-distal1.3 t-score
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- Radius ultra-distal-1.0 t-score
Healthy VolunteersDXA Scan MeasurementsNo Fracture- Femur neck0.3 t-score
Healthy VolunteersDXA Scan MeasurementsNo Fracture- L1-L4 VB0.5 t-score
Healthy VolunteersDXA Scan MeasurementsNo Fracture- Hip0.7 t-score
Healthy VolunteersDXA Scan MeasurementsNo Fracture- Radius ultra-distal0.2 t-score
Healthy VolunteersDXA Scan MeasurementsNo Fracture- Radius distal-third0.6 t-score
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- Femur neck1.9 t-score
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- L1-L4 VB1.9 t-score
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- Hip0.8 t-score
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- Radius distal-third0.7 t-score
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- Radius ultra-distal1.3 t-score
Primary

DXA Scan Measurements

Bone Mineral Density

Time frame: Within a week before or after surgery to repair distal radius fracture

Population: Distal Radius Fracture Operative Group- Includes 9 high energy fracture and 14 low energy fracture subjects.~High Energy: 1 did not have L1-L4 scanned, 2 did not receive calculations due to age. Low Energy- 3 did not have a DXA scan.~Healthy Volunteers- 1 subject did not have a DXA scan.

ArmMeasureGroupValue (MEDIAN)
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- L1 -L4 VB1.119 g/cm^2
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- L1-L4 VB1.165 g/cm^2
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- Hip1.088 g/cm^2
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- Hip0.909 g/cm^2
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- Femur neck1.063 g/cm^2
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- Femur neck0.920 g/cm^2
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- Radius distal-third0.938 g/cm^2
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- Radius distal-third0.833 g/cm^2
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- Radius ultra-distal0.924 g/cm^2
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- Radius ultra-distal0.810 g/cm^2
Healthy VolunteersDXA Scan MeasurementsNo fracture- Femur neck1.008 g/cm^2
Healthy VolunteersDXA Scan MeasurementsNo Fracture- L1-L4 VB1.138 g/cm^2
Healthy VolunteersDXA Scan MeasurementsNo Fracture- Hip0.988 g/cm^2
Healthy VolunteersDXA Scan MeasurementsNo Fracture- Radius ultra-distal0.883 g/cm^2
Healthy VolunteersDXA Scan MeasurementsNo Fracture- Radius distal-third0.887 g/cm^2
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- Femur neck1.322 g/cm^2
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- L1 -L4 VB1.475 g/cm^2
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- Hip1.197 g/cm^2
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- Radius distal-third1.059 g/cm^2
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- Radius ultra-distal1.071 g/cm^2
Primary

DXA Scan Measurements

Bone Mineral Content

Time frame: Within a week before or after surgery to repair distal radius fracture

Population: Distal Radius Fracture Operative Group- Includes 9 high energy fracture and 14 low energy fracture subjects.~High Energy: 1 did not have L1-L4 scanned, 2 did not receive calculations due to age. Low Energy- 3 did not have a DXA scan.~Healthy Volunteers- 1 subject did not have a DXA scan.

ArmMeasureGroupValue (MEDIAN)
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- Radius ultra-distal2.39 g
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- Femur neck4.848 g
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy L1-L4 VB74.24 g
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- Radius distal-third2.433 g
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy L1-L4 VB65.04 g
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- Hip43.03 g
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- Radius ultra-distal1.713 g
Distal Radius Fracture Operative GroupDXA Scan MeasurementsLow Energy- Hip33.5 g
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- Radius distal-third3.07 g
Distal Radius Fracture Operative GroupDXA Scan MeasurementsHigh Energy- Femur neck6.05 g
Healthy VolunteersDXA Scan MeasurementsNo Fracture- Radius ultra-distal1.87 g
Healthy VolunteersDXA Scan MeasurementsNo Fracture L1-L4 VB70.19 g
Healthy VolunteersDXA Scan MeasurementsNo Fracture- Hip36.97 g
Healthy VolunteersDXA Scan MeasurementsNo Fracture- Femur neck5.49 g
Healthy VolunteersDXA Scan MeasurementsNo Fracture- Radius distal-third2.43 g
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy L1-L4 VB98.87 g
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- Femur neck7.26 g
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- Radius ultra-distal2.43 g
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- Hip44.97 g
Distal Radius Fracture Non-Operative GroupDXA Scan MeasurementsHigh Energy- Radius distal-third3.64 g
Primary

MRI Scan Measurements

Bound Water Fraction

Time frame: Within a week before or after surgery to repair distal radius fracture

Population: Distal Radius Fracture Nonoperative Group- 2 subjects did not have MRI scan data.~Healthy Volunteers- 1 subject did not take part in the MRI scan.~Distal Radius Fracture Operative Group- 8 Low Energy and 6 high energy subjects did not take part in the MRI scan. 3 high energy subjects did not have usable MRI data due to technical issues.

ArmMeasureGroupValue (MEDIAN)
Distal Radius Fracture Operative GroupMRI Scan MeasurementsHigh Energy Fracture12.6 percentage of bound water fraction
Distal Radius Fracture Operative GroupMRI Scan MeasurementsLow Energy Fracture16.6 percentage of bound water fraction
Healthy VolunteersMRI Scan MeasurementsNo fracture25.9 percentage of bound water fraction
Primary

MRI Scan Measurements

Pore Water Fraction

Time frame: Within a week before or after surgery to repair distal radius fracture

Population: Distal Radius Fracture Nonoperative Group- 2 subjects did not have MRI scan data.~Healthy Volunteers- 1 subject did not take part in the MRI scan.~Distal Radius Fracture Operative Group- 8 Low Energy and 6 high energy subjects did not take part in the MRI scan. 3 high energy subjects did not have usable MRI data due to technical issues.

ArmMeasureGroupValue (MEDIAN)
Distal Radius Fracture Operative GroupMRI Scan MeasurementsHigh Energy Fracture12.9 percentage of pore water fraction
Distal Radius Fracture Operative GroupMRI Scan MeasurementsLow Energy Fracture17.4 percentage of pore water fraction
Healthy VolunteersMRI Scan MeasurementsNo fracture10.4 percentage of pore water fraction
Primary

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.

Time frame: Within a week before or after surgery to repair distal radius fracture

Population: Only Distal Radius Fracture Operative Group subjects underwent Osteoprobe measurements where Bone Material Strength index (BMSi) was obtained.

ArmMeasureGroupValue (MEDIAN)
Distal Radius Fracture Operative GroupOsteoprobe MeasurementsHigh Energy73.3 Index
Distal Radius Fracture Operative GroupOsteoprobe MeasurementsLow Energy76.3 Index
Secondary

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.

Time frame: Baseline/One-Time Completion and Post-op/-treatment: 3, 6, and 12 weeks

Population: Distal Radius Fracture Operative Group- Includes 11 high energy fracture and 17 low energy fracture subjects.~Healthy Volunteers were only asked to complete the DASH at the baseline visit.

ArmMeasureGroupValue (MEAN)Dispersion
Distal Radius Fracture Operative GroupPatient-reported MeasurementsLow Energy- 12 Week21.92 score on a scaleStandard Deviation 20.67
Distal Radius Fracture Operative GroupPatient-reported MeasurementsLow Energy- 3 Week50.73 score on a scaleStandard Deviation 18.85
Distal Radius Fracture Operative GroupPatient-reported MeasurementsHigh Energy- 6 Week28.43 score on a scaleStandard Deviation 24.46
Distal Radius Fracture Operative GroupPatient-reported MeasurementsLow Energy- 6 Week38.93 score on a scaleStandard Deviation 20.98
Distal Radius Fracture Operative GroupPatient-reported MeasurementsHigh Energy- 12 Week3.33 score on a scaleStandard Deviation 4.45
Distal Radius Fracture Operative GroupPatient-reported MeasurementsHigh Energy- Baseline41.18 score on a scaleStandard Deviation 28.08
Distal Radius Fracture Operative GroupPatient-reported MeasurementsLow Energy- Baseline59.89 score on a scaleStandard Deviation 18.5
Distal Radius Fracture Operative GroupPatient-reported MeasurementsHigh Energy- 3 Week35.39 score on a scaleStandard Deviation 25.13
Healthy VolunteersPatient-reported MeasurementsNo Fracture- Baseline0.83 score on a scaleStandard Deviation 1.04
Distal Radius Fracture Non-Operative GroupPatient-reported MeasurementsHigh Energy- Baseline27.66 score on a scaleStandard Deviation 6.83
Distal Radius Fracture Non-Operative GroupPatient-reported MeasurementsHigh Energy- 6 Week38.93 score on a scaleStandard Deviation 20.98
Distal Radius Fracture Non-Operative GroupPatient-reported MeasurementsHigh Energy- 12 Week0.84 score on a scaleStandard Deviation 0.84
Distal Radius Fracture Non-Operative GroupPatient-reported MeasurementsHigh Energy- 3 Week7.50 score on a scaleStandard Deviation 6.66
Secondary

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.

Time frame: Baseline and Post-op/-treatment: 3, 6, and 12 weeks

Population: Only subjects with a fracture were asked to complete the PRWE survey. Distal Radius Fracture Operative Group- Includes 11 high energy fracture and 17 low energy fracture subjects.

ArmMeasureGroupValue (MEAN)Dispersion
Distal Radius Fracture Operative GroupPatient-reported MeasurementsHigh Energy- 3 Week52.44 score on a scaleStandard Deviation 27.04
Distal Radius Fracture Operative GroupPatient-reported MeasurementsLow Energy- 12 Week28.23 score on a scaleStandard Deviation 25.99
Distal Radius Fracture Operative GroupPatient-reported MeasurementsHigh Energy- Baseline70.45 score on a scaleStandard Deviation 18.89
Distal Radius Fracture Operative GroupPatient-reported MeasurementsLow Energy- 3 Week61.11 score on a scaleStandard Deviation 15.29
Distal Radius Fracture Operative GroupPatient-reported MeasurementsHigh Energy- 6 Week39.53 score on a scaleStandard Deviation 24.89
Distal Radius Fracture Operative GroupPatient-reported MeasurementsLow Energy- 6 Week47.69 score on a scaleStandard Deviation 25.43
Distal Radius Fracture Operative GroupPatient-reported MeasurementsHigh Energy-12 Week5.29 score on a scaleStandard Deviation 5.37
Distal Radius Fracture Operative GroupPatient-reported MeasurementsLow Energy- Baseline76.30 score on a scaleStandard Deviation 16.85
Distal Radius Fracture Non-Operative GroupPatient-reported MeasurementsHigh Energy- Baseline43.5 score on a scaleStandard Deviation 4.5
Distal Radius Fracture Non-Operative GroupPatient-reported MeasurementsHigh Energy-12 Week2 score on a scaleStandard Deviation 2
Distal Radius Fracture Non-Operative GroupPatient-reported MeasurementsHigh Energy- 3 Week13.5 score on a scaleStandard Deviation 7.5
Distal Radius Fracture Non-Operative GroupPatient-reported MeasurementsHigh Energy- 6 Week10 score on a scaleStandard Deviation 6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026