GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients

AgNovos

Status: Completed

Conditions: Osteoporosis

Study type: Observational

Funder types: Industry

Identifiers

NCT05966974

AGN-CIP-302

Details and patient eligibility

About

The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. 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 outside of any other clinical study protocols between September 2019 and November 2022. A prospective questionnaire will be included to evaluate self-reported subject experiences.

Enrollment: 44 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has previously received AGN1 LOEP treatment between September 2019 and November 2022.
• Subject has willingness to participate in the study.
• Subject can give written informed consent to allow for data collection.

Exclusion criteria

• The subject's AGN1 LOEP treatment was previously performed as part of a prior protocoled clinical study.

Trial design

44 participants in 1 patient group

Patients treated with AGN1 LOEP