New Tools for Assessing Fracture Risk

NCT02436356 | Terminated Results DMC FDA Device

• 2 other identifiers: 141125UL1TR000445
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Fracture Risk Assessment

Outcome Measures

Primary Outcomes (6)

• 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

• MRI Scan Measurements

  Bound Water Fraction

  Within a week before or after surgery to repair distal radius fracture

• MRI Scan Measurements

  Pore Water Fraction

  Within a week before or after surgery to repair distal radius fracture

• DXA Scan Measurements

  Bone Mineral Density

  Within a week before or after surgery to repair distal radius fracture

• DXA Scan Measurements

  Bone Mineral Content

  Within a week before or after surgery to repair distal radius fracture

• 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 Outcomes (2)

• Patient-reported Measurements

  Baseline/One-Time Completion and Post-op/-treatment: 3, 6, and 12 weeks

• Patient-reported Measurements

  Baseline and Post-op/-treatment: 3, 6, and 12 weeks

Study Arms (3)

Distal Radius Fracture Operative Group

ACTIVE COMPARATOR

Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.

Device: Osteoprobe-Reference Point Indentation (RPI); Radiation: Dual-energy X-ray absorptiometry (DXA) Scans; Radiation: MRI

Healthy Volunteers (Non Fracture Group)

ACTIVE COMPARATOR

Healthy volunteers will undergo DXA and MRI scans.

Radiation: Dual-energy X-ray absorptiometry (DXA) Scans; Radiation: MRI

Distal Radius Fracture Non-operative Group

ACTIVE COMPARATOR

Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.

Radiation: Dual-energy X-ray absorptiometry (DXA) Scans; Radiation: MRI

Interventions

Osteoprobe-Reference Point Indentation (RPI) DEVICE

Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).

Distal Radius Fracture Operative Group

Dual-energy X-ray absorptiometry (DXA) Scans RADIATION

Assessment of Fracture Risk

Distal Radius Fracture Non-operative Group; Distal Radius Fracture Operative Group; Healthy Volunteers (Non Fracture Group)

MRI RADIATION

Determines bound water and pore water of bone.

Distal Radius Fracture Non-operative Group; Distal Radius Fracture Operative Group; Healthy Volunteers (Non Fracture Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Number of patients in Arm#1= 60 patients
• 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.
• 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.
• English speaking due to feasibility of employing study personnel to deliver and assess study intervention.
• Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
• Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years
• Patients who have Type 1 diabetes
• Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)
• Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use
• Patients that would not be able to have a DXA scan (weight \>350lbs, hardware in hips, patients that have lap band device)
• Patients who are pregnant or who think they may be pregnant
• Patients that have a medical contraindication to MRI (if patients are undergoing a study MRI)
• Patients who have concurrent, bilateral upper extremity fractures where hardware or casting may affect study scan measurements
• Patients who have distal radial shaft fractures
• Number of patients in Arm#2= 40 patients

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• ActiveLife Scientific: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Vanderbilt Univeristy Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

Early termination of the study occurred in February 2020 when the FDA determined the OsteoProbe is a significant risk device that would require an IDE (Investigational Device Exemption).

Results Point of Contact

• Title: Jeffry S. Nyman, Ph.D.
• Organization: Vanderbilt University Medical Center

jeffry.s.nyman@vumc.org

615-936-6296

Study Officials

• Jeffry S Nyman, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedics and Rehabilitation

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 6, 2015
• Study Start: June 30, 2015
• Primary Completion: May 23, 2018
• Study Completion: November 8, 2018
• Last Updated: November 2, 2020
• Results First Posted: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)