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.
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.