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NCT02436356 · ClinicalTrials.gov registry record · NA
New Tools for Assessing Fracture Risk
A NA study, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT02436356: Clinical Trial NA study, sponsored by Vanderbilt University Medical Center.
NCT02436356 is a NA study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02436356, a NA study, was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study 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.
Primary Outcome
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 ID
Interventions
- RADIATION MRI
- DEVICE Osteoprobe-Reference Point Indentation (RPI)
- RADIATION Dual-energy X-ray absorptiometry (DXA) Scans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2015-06-30 |
| Est. Completion | 2018-11-08 |
| Phase | NA |
Why NCT02436356 stopped before completion
NCT02436356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which MRI is the first listed.
NCT02436356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02436356 about?
NCT02436356 is a clinical study titled "New Tools for Assessing Fracture Risk". 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 du...
What is the current status of trial NCT02436356?
This trial is currently terminated. It is a NA study. The enrollment target is 48 participants. The study started on 2015-06-30. Estimated completion is 2018-11-08.
What interventions are being tested in trial NCT02436356?
The interventions under investigation include: MRI (RADIATION), Osteoprobe-Reference Point Indentation (RPI) (DEVICE), Dual-energy X-ray absorptiometry (DXA) Scans (RADIATION).
Who is sponsoring clinical trial NCT02436356?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02436356's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 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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