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RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis

StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Study Identification, Study Status, Oversight, Conditionsv4
  2. Primary completion date: Aug 2023 to Dec 2025
    • Study completion date: Aug 2025 to Dec 2026
    v3
  3. Study title shortened, about 2 wordsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05202678
Lead Sponsor AgNovos Healthcare, LLC
Conditions
(from sponsor)		 Osteoporosis
Related terms Hip Fractures, Osteoporosis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov