Fracture Risk Assessment, Osteoporosis
Conditions
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
Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
Assessment of Fracture Risk
Determines bound water and pore water of bone.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| MRI Scan Measurements | Within a week before or after surgery to repair distal radius fracture | Bound Water Fraction |
| DXA Scan Measurements | Within a week before or after surgery to repair distal radius fracture | Bone Mineral Density |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Measurements | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Excluded by MRI Screening | 0 | 0 | 2 |
| Overall Study | Excluded due to other medical conditions | 3 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Surgical Approach (Dorsal not volar) | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Distal Radius Fracture Operative Group | Healthy Volunteers (Non Fracture Group) | Distal Radius Fracture Non-operative Group | Total |
|---|---|---|---|---|
| Age, Continuous | 47 years | 44 years | 30 years | 40 years |
| Body Mass Index (BMI) | 27.9 kg/m2 | 27.55 kg/m2 | 25.61 kg/m2 | 27.7 kg/m2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 9 Participants | 2 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 10 Participants | 2 Participants | 37 Participants |
| Region of Enrollment United States | 28 participants | 10 participants | 2 participants | 40 participants |
| Sex: Female, Male Female | 19 Participants | 7 Participants | 0 Participants | 26 Participants |
| Sex: Female, Male Male | 9 Participants | 3 Participants | 2 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 10 | 0 / 2 |
| other Total, other adverse events | 0 / 28 | 0 / 10 | 0 / 2 |
| serious Total, serious adverse events | 0 / 28 | 0 / 10 | 0 / 2 |
Outcome results
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- L1-L4 VB | 0.8 t-score |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- L1-L4 VB | 0.6 t-score |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- Hip | 1.2 t-score |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- Hip | -0.2 t-score |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- Femur neck | 0.7 t-score |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- Femur neck | -0.4 t-score |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- Radius distal-third | 0.7 t-score |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- Radius distal-third | 0.8 t-score |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- Radius ultra-distal | 1.3 t-score |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- Radius ultra-distal | -1.0 t-score |
| Healthy Volunteers | DXA Scan Measurements | No Fracture- Femur neck | 0.3 t-score |
| Healthy Volunteers | DXA Scan Measurements | No Fracture- L1-L4 VB | 0.5 t-score |
| Healthy Volunteers | DXA Scan Measurements | No Fracture- Hip | 0.7 t-score |
| Healthy Volunteers | DXA Scan Measurements | No Fracture- Radius ultra-distal | 0.2 t-score |
| Healthy Volunteers | DXA Scan Measurements | No Fracture- Radius distal-third | 0.6 t-score |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- Femur neck | 1.9 t-score |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- L1-L4 VB | 1.9 t-score |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- Hip | 0.8 t-score |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- Radius distal-third | 0.7 t-score |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- Radius ultra-distal | 1.3 t-score |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- L1 -L4 VB | 1.119 g/cm^2 |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- L1-L4 VB | 1.165 g/cm^2 |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- Hip | 1.088 g/cm^2 |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- Hip | 0.909 g/cm^2 |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- Femur neck | 1.063 g/cm^2 |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- Femur neck | 0.920 g/cm^2 |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- Radius distal-third | 0.938 g/cm^2 |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- Radius distal-third | 0.833 g/cm^2 |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- Radius ultra-distal | 0.924 g/cm^2 |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- Radius ultra-distal | 0.810 g/cm^2 |
| Healthy Volunteers | DXA Scan Measurements | No fracture- Femur neck | 1.008 g/cm^2 |
| Healthy Volunteers | DXA Scan Measurements | No Fracture- L1-L4 VB | 1.138 g/cm^2 |
| Healthy Volunteers | DXA Scan Measurements | No Fracture- Hip | 0.988 g/cm^2 |
| Healthy Volunteers | DXA Scan Measurements | No Fracture- Radius ultra-distal | 0.883 g/cm^2 |
| Healthy Volunteers | DXA Scan Measurements | No Fracture- Radius distal-third | 0.887 g/cm^2 |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- Femur neck | 1.322 g/cm^2 |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- L1 -L4 VB | 1.475 g/cm^2 |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- Hip | 1.197 g/cm^2 |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- Radius distal-third | 1.059 g/cm^2 |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- Radius ultra-distal | 1.071 g/cm^2 |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- Radius ultra-distal | 2.39 g |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- Femur neck | 4.848 g |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy L1-L4 VB | 74.24 g |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- Radius distal-third | 2.433 g |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy L1-L4 VB | 65.04 g |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- Hip | 43.03 g |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- Radius ultra-distal | 1.713 g |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | Low Energy- Hip | 33.5 g |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- Radius distal-third | 3.07 g |
| Distal Radius Fracture Operative Group | DXA Scan Measurements | High Energy- Femur neck | 6.05 g |
| Healthy Volunteers | DXA Scan Measurements | No Fracture- Radius ultra-distal | 1.87 g |
| Healthy Volunteers | DXA Scan Measurements | No Fracture L1-L4 VB | 70.19 g |
| Healthy Volunteers | DXA Scan Measurements | No Fracture- Hip | 36.97 g |
| Healthy Volunteers | DXA Scan Measurements | No Fracture- Femur neck | 5.49 g |
| Healthy Volunteers | DXA Scan Measurements | No Fracture- Radius distal-third | 2.43 g |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy L1-L4 VB | 98.87 g |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- Femur neck | 7.26 g |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- Radius ultra-distal | 2.43 g |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- Hip | 44.97 g |
| Distal Radius Fracture Non-Operative Group | DXA Scan Measurements | High Energy- Radius distal-third | 3.64 g |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Distal Radius Fracture Operative Group | MRI Scan Measurements | High Energy Fracture | 12.6 percentage of bound water fraction |
| Distal Radius Fracture Operative Group | MRI Scan Measurements | Low Energy Fracture | 16.6 percentage of bound water fraction |
| Healthy Volunteers | MRI Scan Measurements | No fracture | 25.9 percentage of bound water fraction |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Distal Radius Fracture Operative Group | MRI Scan Measurements | High Energy Fracture | 12.9 percentage of pore water fraction |
| Distal Radius Fracture Operative Group | MRI Scan Measurements | Low Energy Fracture | 17.4 percentage of pore water fraction |
| Healthy Volunteers | MRI Scan Measurements | No fracture | 10.4 percentage of pore water fraction |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Distal Radius Fracture Operative Group | Osteoprobe Measurements | High Energy | 73.3 Index |
| Distal Radius Fracture Operative Group | Osteoprobe Measurements | Low Energy | 76.3 Index |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Distal Radius Fracture Operative Group | Patient-reported Measurements | Low Energy- 12 Week | 21.92 score on a scale | Standard Deviation 20.67 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | Low Energy- 3 Week | 50.73 score on a scale | Standard Deviation 18.85 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | High Energy- 6 Week | 28.43 score on a scale | Standard Deviation 24.46 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | Low Energy- 6 Week | 38.93 score on a scale | Standard Deviation 20.98 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | High Energy- 12 Week | 3.33 score on a scale | Standard Deviation 4.45 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | High Energy- Baseline | 41.18 score on a scale | Standard Deviation 28.08 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | Low Energy- Baseline | 59.89 score on a scale | Standard Deviation 18.5 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | High Energy- 3 Week | 35.39 score on a scale | Standard Deviation 25.13 |
| Healthy Volunteers | Patient-reported Measurements | No Fracture- Baseline | 0.83 score on a scale | Standard Deviation 1.04 |
| Distal Radius Fracture Non-Operative Group | Patient-reported Measurements | High Energy- Baseline | 27.66 score on a scale | Standard Deviation 6.83 |
| Distal Radius Fracture Non-Operative Group | Patient-reported Measurements | High Energy- 6 Week | 38.93 score on a scale | Standard Deviation 20.98 |
| Distal Radius Fracture Non-Operative Group | Patient-reported Measurements | High Energy- 12 Week | 0.84 score on a scale | Standard Deviation 0.84 |
| Distal Radius Fracture Non-Operative Group | Patient-reported Measurements | High Energy- 3 Week | 7.50 score on a scale | Standard Deviation 6.66 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Distal Radius Fracture Operative Group | Patient-reported Measurements | High Energy- 3 Week | 52.44 score on a scale | Standard Deviation 27.04 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | Low Energy- 12 Week | 28.23 score on a scale | Standard Deviation 25.99 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | High Energy- Baseline | 70.45 score on a scale | Standard Deviation 18.89 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | Low Energy- 3 Week | 61.11 score on a scale | Standard Deviation 15.29 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | High Energy- 6 Week | 39.53 score on a scale | Standard Deviation 24.89 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | Low Energy- 6 Week | 47.69 score on a scale | Standard Deviation 25.43 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | High Energy-12 Week | 5.29 score on a scale | Standard Deviation 5.37 |
| Distal Radius Fracture Operative Group | Patient-reported Measurements | Low Energy- Baseline | 76.30 score on a scale | Standard Deviation 16.85 |
| Distal Radius Fracture Non-Operative Group | Patient-reported Measurements | High Energy- Baseline | 43.5 score on a scale | Standard Deviation 4.5 |
| Distal Radius Fracture Non-Operative Group | Patient-reported Measurements | High Energy-12 Week | 2 score on a scale | Standard Deviation 2 |
| Distal Radius Fracture Non-Operative Group | Patient-reported Measurements | High Energy- 3 Week | 13.5 score on a scale | Standard Deviation 7.5 |
| Distal Radius Fracture Non-Operative Group | Patient-reported Measurements | High Energy- 6 Week | 10 score on a scale | Standard Deviation 6 |