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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07594639

Enrollment

305

Registered

2026-05-19

Start date

2026-06-01

Completion date

2026-09-30

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Bone mineral density, Femoral strength, Hip fracture, Local osteo-enhancement procedure, LOEP, Proximal femur, Osteogenesis Imperfecta, OI, Hypophosphatasia, HPP

Brief summary

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

DEVICEAGN1 LOEP

Patients treated with AGN1 LOEP

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Incidence of fragility fractures of AGN1 LOEP treated hip	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	Through study completion, an average of 6 months.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026