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NCT03463850 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by State University of New York - Upstate Medical University.

Completed
Registry status
NA
Development phase
7
Enrollment target

NCT03463850: Completed NA study, sponsored by State University of New York - Upstate Medical University.

NCT03463850 is a NA study that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03463850, a NA study, has completed, sponsored by State University of New York - Upstate Medical University.

COMPLETED
Registry status
NA
Development phase
7 participants
Enrollment target

Study 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.

Primary Outcome

Computer algorithms will be developed to differentiate patients with high risk of fracture from patients with low risk of fracture.

Interventions

  • RADIATION DEXA
  • RADIATION Dual Energy CT (DECT)

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2016-06
Est. Completion 2023-11
Phase NA

What the finished NCT03463850 record still lists

NCT03463850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which DEXA is the first listed.

NCT03463850 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03463850 about?

NCT03463850 is a clinical study titled "Analysis of Bone Micro-Architecture as a Clinical Biomarker for Image-Based 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-ra...

What is the current status of trial NCT03463850?

This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2016-06. Estimated completion is 2023-11.

What interventions are being tested in trial NCT03463850?

The interventions under investigation include: DEXA (RADIATION), Dual Energy CT (DECT) (RADIATION).

Who is sponsoring clinical trial NCT03463850?

This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03463850's enrollment target sits among peer trials

7 1982nd of 2000 higher than 18 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03463850, the US trial registry maintained by the National Library of Medicine. NCT03463850 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.