Clinical Trial

RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis

Recruiting
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Record status
This record was last updated January 31, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study. The study will collect procedural, short- and long-term data on the safety and clinical performance of AGN1 LOEP in the post-market setting in European countries where AGN1 LOEP is commercially available. AGN1 is intended to form new bone in voids in the proximal femur of women with osteoporosis.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-01-20; most recent amendment 2025-01-29.
Trial Details
NCT Number NCT05202678
Lead Sponsor AgNovos Healthcare, LLC
Conditions Osteoporosis
Enrollment 150 participants
Start Date 2021-07-05
Primary Completion 2025-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-01-31