Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT02436356
Eligibility 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.
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02436356
Study Brief:
Protocol Section:
NCT02436356