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

Completed · Not applicable

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT03463850

Run by

State University of New York - Upstate Medical University

People needed

7

Starts

2016-06-01

Expected to finish

2023-11-01

Last updated by the study team

2026-04-28

Who can join

Age: 60 and older. Sex: female. Healthy volunteers: not accepted.

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)

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.