Clinical trial NCT02436356: New Tools for Assessing Fracture Risk
Official title: New Tools for Assessing Fracture Risk
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoporosis
Fracture Risk Assessment
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: ActiveLife Scientific
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2015-05-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Osteoprobe Measurements
timeFrame: Within a week before or after surgery to repair distal radius fracture
measure: MRI Scan Measurements
timeFrame: Within a week before or after surgery to repair distal radius fracture
measure: MRI Scan Measurements
timeFrame: Within a week before or after surgery to repair distal radius fracture
measure: DXA Scan Measurements
timeFrame: Within a week before or after surgery to repair distal radius fracture
measure: DXA Scan Measurements
timeFrame: Within a week before or after surgery to repair distal radius fracture
measure: DXA Scan Measurements
timeFrame: Within a week before or after surgery to repair distal radius fracture
Secondary outcomes:
measure: Patient-reported Measurements
timeFrame: Baseline/One-Time Completion and Post-op/-treatment: 3, 6, and 12 weeks
measure: Patient-reported Measurements
timeFrame: Baseline and Post-op/-treatment: 3, 6, and 12 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Univeristy Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jeffry S Nyman, PhD
role: PRINCIPAL_INVESTIGATOR
References: