ClinicalTrials.gov record NCT07594639

GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Retrospective Study of OSSURE LOEP in Osteopenic and Osteoporotic Subjects in the Commercial European Market

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

SexAll

LocationBelgium

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A retrospective observational study of people previously treated with the AGN1 LOEP device in the proximal femur between September 2019 and January 2026. The study reviews past clinical records and will contact enrolled participants by telephone to record any fractures after treatment. Subjects treated as part of a prior AgNovos‑protocoled clinical study are excluded; informed consent is required for living subjects (not required for deceased subjects).

What it is studying. The study is collecting retrospective clinical data to describe the safety and performance of AGN1 LOEP in the proximal femur. It focuses on the incidence of fragility fractures of the treated hip and the incidence of adverse events or serious adverse events judged at least possibly related to the procedure or device, tracked through an average follow-up of six months.

What the researchers hope to learn. To gather real-world, retrospective data on the safety and performance of AGN1 LOEP in the proximal femur, specifically the frequency of treated-hip fragility fractures and procedure- or device-related adverse events.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated between September 2019 and January 2026. Subjects treated as part of an AgNovos prior protocoled study are excluded. Investigators are asked to reach out to all subjects that were previously treated with the AGN1 LOEP Kit in the proximal femur. Subject informed consent is obtained before a subject is enrolled into the study. Subjects treated but not enrolled are documented in a log with the reason why a subject did not participate. This log is kept on site. Enrolled subjects will be contacted per telephone to collect information about any fractures sustained post-AGN1 LOEP treatment.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device: AGN1 LOEP

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Enrolled participants give written informed consent (unless deceased) and allow the study team to collect retrospective medical-record data about their AGN1 LOEP treatment, safety events, and device performance. Study staff will contact enrolled participants by telephone to ask about any fractures since the AGN1 LOEP procedure. If a previously treated person does not enroll, sites document that person in a log with the reason for non-participation.

How the study is structured. A retrospective observational cohort study. Investigators will collect past medical record information for people who received AGN1 LOEP in the proximal femur and will contact enrolled participants by phone for fracture information. The study is non-randomized and non-blinded; subjects previously treated as part of an AgNovos protocoled clinical study are excluded. Informed consent is obtained from living subjects; obtaining consent is not required for deceased subjects per the registry.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Osteoporosis. Does it apply to my diagnosis?
This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
The listed sites are in Belgium. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on hypophosphatasia

Clinical trials9 trials listed for hypophosphatasiaEvery trial the registry lists for hypophosphatasia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in hypophosphatasia researchLatest monthly update: September 2026. Includes: Early lab flag. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Jun 1, 2026 (estimated)
Primary completion: Sep 30, 2026 (estimated)
Study completion: Sep 30, 2026 (estimated)
Target enrollment: 305 participants (estimated)
Last updated on registry: May 19, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: AgNovos Healthcare, LLC

Participating sites (1)

Vitaz
Sint-Niklaas · Belgium
- Jo De Schepper · jo.deschepper@vitaz.be

Terms used on this page · explanations by MedicalUpdates.ai

randomized: Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
blinded: Who does not know which intervention a participant is receiving. It can apply to participants, the people giving the treatment, those assessing results, or those analysing the data.
informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials