Could a new injection replace bone cement for spine fractures?
NCT ID NCT04835428
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a new device (AGN1 LOEP) to standard bone cement for treating painful spine fractures caused by osteoporosis. The new device is injected into the broken vertebra, where it hardens and then slowly gets replaced by new bone. The trial involves 408 adults aged 50 and older with recent fractures. The goal is to see if the new device works as well as cement for pain relief and function, while also promoting bone regrowth.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
AGN1 LOEP SV Kit (a device that is injected into the fractured vertebra, resorbed, and replaced by new bone)
What this could lead to
If it works, this could offer a treatment for painful spine fractures that helps the body regrow bone rather than just filling the crack with cement.
What could go wrong
This is an early-stage non-inferiority trial, so the new device may not be as effective as standard cement. Risks include device-related complications or the need for further surgery.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
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Cleveland Clinic Florida
Stuart, Florida, 34994, United States
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Elite Pain and Spine Institute
Mesa, Arizona, 85203, United States
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Endeavor Health
Evanston, Illinois, 60201, United States
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Lahey Medical Center
Burlington, Massachusetts, 01805, United States
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Louisiana Spine Institute
Shreveport, Louisiana, 71101, United States
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Montefiore
The Bronx, New York, 10467, United States
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Orlando Neurosurgery (Conquest Research)
Orlando, Florida, 32804, United States
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Pinehurst Surgical Clinic
Pinehurst, North Carolina, 28374, United States
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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Texas Back Institute
Plano, Texas, 75093, United States
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University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160, United States