RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis (NCT05202678) | Clinical Trial Compass
RecruitingNot Applicable
RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
Belgium150 participantsStarted 2021-07-05
Plain-language 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.
Who can participate
SexFEMALE
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Inclusion criteria
✓. Subject is a postmenopausal female (at least 1-year post menses).
✓. Subject has bone loss in the hip attributable to osteoporosis as defined by a femoral neck DXA T-score of -2.5 or less.
✓. Subject has at least one hip without previous surgery or fracture.
✓. Subject is medically stable from any previous treatment or medical procedure in the opinion of the investigator and with an ASA score of I or II.
✓. Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
✓. Subject is capable of giving written informed consent to participate in the study.
Exclusion criteria
✕. Subject is less than 3 months removed from having a hip fracture repair or prosthesis or elective Total Hip Arthroplasty (THA).
✕. Subject has progressive increase in hip pain over the previous six (6) months that in the opinion of the Investigator suggests moderate to severe intra-articular arthritis, labral tear, extraarticular soft tissue pathology, referred pain, tumor, stress fracture or infection.
✕. Subject is dependent on the use of a wheelchair or is bedridden.
✕. Subject has albumin corrected serum calcium levels outside the normal lab range or has a pre-existing calcium metabolism disorder (e.g., hypercalcemia).