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

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 19, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07594639
Lead Sponsor AgNovos Healthcare, LLC
Conditions
(from sponsor)		 Osteoporosis
Related terms Hip Fractures, Hypophosphatasia, Osteogenesis Imperfecta, Osteoporosis
Enrollment 305 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov