Analysis of Bone Micro-Architecture as a Clinical Biomarker for Image-Based Fracture Risk Estimation.

Multidimensional Analysis of Bone Micro-Architecture as a Clinical Biomarker for Image-Based Quantitative Fracture Risk Estimation.

Osteoporosis is a common disease among elderly people, which leads to an increased bone fracture risk. Bone fractures can greatly reduce quality of life and increase age-related problems including reduced life expectancy. In clinical practice, a bone mineral density (BMD) scan using dual-energy X-ray absorptiometry (DEXA) is used for diagnosing osteoporosis. However, DEXA does not always accurately predict who will develop fractures and who will not. This is because bone mineral density alone does not capture all of the factors that contribute to bone strength. One factor bone mineral density does not measure is trabecular microarchitecture of bone (structure of bone).

Our goal in this study is to use a specialized CT scan called Dual-Energy CT (DECT) to capture information about the trabecular (spongy) bone in the vertebra of the lower (lumbar) spine. Research has shown that this kind of information helps in predicting bone strength in bone specimens. The investigator will use this information to develop a method to more accurately predict which patients are likely to experience fractures of the lumbar vertebra. These are the most common type of fractures associated with osteoporosis.

The participant is being asked to participate in this research study because a physician is treating the participant for osteoporosis and the participant has met the initial criteria to participate in the study. Participation in this study involves having a DECT scan, as well as a DEXA scan if the participant has not had one recently (within two months).

Research studies include only those individuals who choose to take part. Please take time to make a decision. Please ask the study doctor or the study staff to explain any words or information that are not understood. The participant may also want to discuss it with family members, friends or other health care providers.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Radiation: Dual Energy CT (DECT); Radiation: DEXA

Detailed Description

Osteoporosis is a common disease among elderly people, the progression of which leads to an increased bone fracture risk, which can adversely affect quality of life and increase age-related morbidity/mortality. The National Osteoporosis Foundation forecast that by 2015, osteoporosis will be responsible for three million fractures resulting in $25.3 billion in healthcare costs. This highlights an urgent demand for methods to accurately predict osteoporotic fracture risk for clinical assessment and management of osteoporosis.

In clinical practice, dual-energy X-ray absorptiometry (DEXA) is the traditional and only method of diagnosing osteoporosis based on BMD measurements. However, DEXA has certain limitations, and a considerable overlap exists in BMD values between individuals who develop fractures and those who do not. This reflects that BMD does not capture all of the factors that contribute to bone strength. One such factor is trabecular microarchitecture of bone, well recognized in the definition of osteoporosis.

Ex vivo studies have demonstrated that trabecular bone microarchitecture constitutes an important component of bone strength, independent of BMD. However, trabecular microarchitecture is not considered in the evaluation of fracture risk in clinical practice. Several imaging techniques have been reviewed as potential candidates for clinical evaluation of trabecular bone microarchitecture. Technological improvements in high resolution X-ray imaging and MRI are providing increasingly accurate data on bone microarchitecture, but can be used only at peripheral sites (femur and forearm) and have not yet been incorporated into standardized clinical imaging protocols due to the lack of central site (lumbar spine) assessment, where osteoporotic fractures are most prevalent.

The current literature suggests a potential to increase the diagnostic accuracy of bone-strength prediction by incorporating advanced mathematical descriptors of bone structure. The project collaborators in Rochester have demonstrated that geometrical features characterizing the femoral trabecular compartment can complement conventional BMD measurements and improve bone strength prediction in ex vivo femur specimens. However, little effort has been made to actually utilize this complementary image information in clinical practice. This study should encourage the further development of these techniques and implementation into clinical practice.

Our goal is to start to bridge the gap between fundamental research on bone strength prediction and clinical management of osteoporosis, reflecting a translational research approach from "bench to bedside". To this end, a novel methodology will be evaluated by both a retrospective analysis and a prospective pilot study. The specific choice of using dual-energy CT (DECT) for the prospective pilot study is motivated by the potential to improve BMD measurement beyond what Quantitative CT (QCT) can, and it also allows for material decomposition into calcium and soft-tissue components, which has applications for other clinically relevant disease entities and will eventually result in the widespread availability of this relatively new technology.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 60 or greater Caucasian female with confirmed osteoporosis via prior DEXA.
• Patients with known vertebral fractures (Genant Grade 2 or higher) and with no fractures (Genant Score <2) from prior DEXA/VFA analysis will be recruited.
• Patients with fractures must have at least one lumbar vertebral body with no fracture(s) (as seen on prior DEXA scan) for analysis.

Exclusion Criteria:

• Incidental finding to include pathology unrelated to osteoporosis that would directly affect bone architecture in the L spine (e.g. lytic bone lesions)
• Study DEXA scan reveals all lumbar vertebra have fractures (Genant >= 2)
• Orthopedic hardware in the lumbar spine region
• Unable to have a CT scan (e.g. too heavy for CT scan table, 660 lb. limit)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-fracture; subjects without a lumbar fracture will have a Dexa scan and Dual Energy CT (DECT) scan for observation/evaluation	Radiation: Dual Energy CT (DECT); Dual Energy CT (DECT); Radiation: DEXA; Dual-energy x-ray absorptiometry for measurement of bone mineral density
Experimental: Fracture; subjects with one or more lumbar fractures will have a Dexa scan andDual Energy CT (DECT) scan for observation/evaluation	Radiation: Dual Energy CT (DECT); Dual Energy CT (DECT); Radiation: DEXA; Dual-energy x-ray absorptiometry for measurement of bone mineral density

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of a predictive software tool that will analyze dual-energy CT scans of the spine, and use the image information to estimate the probability of the patient to suffer an osteoporotic fracture.	Computer algorithms will be developed to differentiate patients with high risk of fracture from patients with low risk of fracture.	2 years

Collaborators and Investigators

• Sponsor: State University of New York - Upstate Medical University
• Investigators: Principal Investigator: Kent Ogden, PhD, Upstate Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: July 14, 2016
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Nutritional and Metabolic Diseases; Osteoporosis
• Other Study ID Numbers: SUNYUMU 713378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes