Looking back at a hip bone implant used in people with osteoporosis
Reviews past safety and results of AGN1 LOEP in osteoporosis patients' hips.
Plain-language title generated from the registry record
Registry title: GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Key facts
- Where
- Sint-Niklaas, BelgiumSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people who already had AGN1 LOEP treatment in the upper thigh bone between September 2019 and January 2026 as part of normal hospital care. Data on safety and fractures are collected afterwards.
- Sex
- All sexes can join.
- Earlier treatment
- Must have had AGN1 LOEP treatment in the proximal femur (upper thigh bone) after September 2019 and before January 2026.
Main reasons for not taking part
- Treatment was given as part of an earlier AgNovos clinical study
- Cannot give written informed consent (not required for deceased subjects)
Read by machine on 13 November 2026.
Where in Belgium
- VitazSint-Niklaas, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AgNovos Healthcare, LLC
- Trial code
- NCT07594639
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
Retrospective Study of OSSURE LOEP in Osteopenic and Osteoporotic Subjects in the Commercial European Market
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.
Inclusion: 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: -The subject's AGN1 LOEP treatment was previously performed as part of an AgNovos prior protocoled clinical study.