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

NCT03463850 | Completed FDA Device

• 1 other identifier: SUNYUMU 713378
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Non-fracture

EXPERIMENTAL

subjects without a lumbar fracture will have a Dexa scan and Dual Energy CT (DECT) scan for observation/evaluation

Radiation: Dual Energy CT (DECT); Radiation: DEXA

Fracture

EXPERIMENTAL

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); Radiation: DEXA

Interventions

Dual Energy CT (DECT) RADIATION

Dual Energy CT (DECT)

Fracture; Non-fracture

DEXA RADIATION

Dual-energy x-ray absorptiometry for measurement of bone mineral density

Fracture; Non-fracture

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Kent Ogden, PhD

  Upstate Medical University

  PRINCIPAL INVESTIGATOR

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: PhD

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: March 13, 2018
• Study Start: June 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: November 1, 2023
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)