New Tools for Assessing Fracture Risk
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Osteoporosis, Orthopedic |
| Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | June 30, 2015 |
| End Date: | February 2020 |
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.
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.
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)
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)
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)
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.
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