New Tools for Assessing Fracture Risk

Osteoporosis Clinical Trial

Official title:

New Tools for Assessing Fracture Risk

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02436356
• Other study ID #: 141125
• Secondary ID: UL1TR000445
• Status: Terminated
• Phase: N/A
• Start date: June 30, 2015
• Est. completion date: November 8, 2018

Study information

• Verified date: October 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: November 8, 2018
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fracture Risk Assessment
• Fractures, Bone
• Osteoporosis

Intervention

Device:
• Osteoprobe-Reference Point Indentation (RPI)
Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).

Radiation:
• Dual-energy X-ray absorptiometry (DXA) Scans
Assessment of Fracture Risk
• MRI
Determines bound water and pore water of bone.

Locations

Country	Name	City	State
United States	Vanderbilt Univeristy Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	ActiveLife Scientific, National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Within a week before or after surgery to repair distal radius fracture
Primary	MRI Scan Measurements	Bound Water Fraction	Within a week before or after surgery to repair distal radius fracture
Primary	MRI Scan Measurements	Pore Water Fraction	Within a week before or after surgery to repair distal radius fracture
Primary	DXA Scan Measurements	Bone Mineral Density	Within a week before or after surgery to repair distal radius fracture
Primary	DXA Scan Measurements	Bone Mineral Content	Within a week before or after surgery to repair distal radius fracture
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.	Within a week before or after surgery to repair distal radius fracture
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.	Baseline/One-Time Completion and Post-op/-treatment: 3, 6, and 12 weeks
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.	Baseline and Post-op/-treatment: 3, 6, and 12 weeks