GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AGN1 LOEP.
- Who it may be relevant to
- Registry conditions: Osteoporosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Retrospective Study of OSSURE LOEP in Osteopenic and Osteoporotic Subjects in the Commercial European Market
Overview
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
- Device AGN1 LOEP
Patients treated with AGN1 LOEP
Primary outcome measures
- Incidence of fragility fractures of AGN1 LOEP treated hip [Time frame: Through study completion, an average of 6 months.]
- Incidence of all adverse events and serious adverse events occurring intraoperative and post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device [Time frame: Through study completion, an average of 6 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Vitaz — Sint-Niklaas
Identifiers
NCT: NCT07594639 · AGN-CIP-304