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New Bone-Strengthening device for osteoporosis under review

NCT ID NCT07594639

Disease control Sponsor: AgNovos Healthcare, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will review medical records and call patients who received AGN1 LOEP, a device injected into the hip bone to treat osteoporosis. Researchers want to see how many patients later had hip fractures and whether any side effects occurred. The goal is to understand how well the device works in real-world use across Europe.

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 (a device injected into the hip bone to strengthen it)
What this could lead to
If results are positive, this could support wider use of AGN1 LOEP to prevent hip fractures in people with osteoporosis.
What could go wrong
This is a retrospective study, not a controlled trial, so it cannot prove cause and effect. Data depends on patient recall and medical records, which may be incomplete.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 305 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All subjects whose AGN1 LOEP treatment was performed outside of a prior AgNovos sponsored clinical study are considered for this study. The study anticipates enrolling up to 305 subjects. The final sample size may be smaller depending on willingness to participate or subject availability

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject has previously received AGN1 LOEP treatment in the proximal femur after September 2019 and before January 2026. * Subject can give written informed consent to allow for data collection. Obtaining informed consent is not required for deceased subjects. Exclusion Criteria: -The subject's AGN1 LOEP treatment was previously performed as part of an AgNovos prior protocoled clinical study.

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Conditions

The condition(s) this trial relates to.

hip fracture hypophosphatasia osteogenesis imperfecta osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoporosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vitaz

    Sint-Niklaas, Belgium

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