NCT05202678

RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis

Prospective, Post-market Evaluation of Safety and Efficacy of a Local Osteo- Enhancement Procedure (LOEP) in the Proximal Femur of Women in Europe with Osteoporosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: AgNovos Healthcare, LLC · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

To qualify for this study, a subject must have at least one intact hip with bone loss attributable to osteoporosis as indicated by a femoral neck DXA T-score of -2.5 or less. Follow-up visits will be conducted at 10 days, 42 days, 12 months, and 24 months after the procedure. Study evaluations at each follow-up visit include general health (physical exam and medical history update), VAS pain (not at 10 days), FES-I (not at 10 days), EQ5D-5L and Parker Mobility. A Timed Up and Go Test is performed at the 10-day, 42-day and 12-month follow-up. Patient satisfaction with outcome of surgery will be asked at the 42-day and the 12-month follow-up. DXA scans and X-rays will be performed at 12 and 24 months.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DEVICE	AGN1 LOEP	Subjects with osteoporosis are treated with AGN1 local osteo-enhancement procedure in the proximal femur

Timeline

• Start date: 2021-07-05
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2022-01-21
• Last updated: 2025-01-31

Locations

1 site across 1 country: Belgium