Local osteo-enhancement procedure significantly increases bone mineral density in the proximal femur of postmenopausal women with osteoporosis at high risk for hip fracture

Introduction Assess improvement of proximal femur bone mineral density (aBMD) in two prospective clinical studies two years after treatment with AGN1 local osteo-enhancement procedure (LOEP).

Methods LOEP was evaluated in prospective, single-armed, cohort clinical studies in USA (COPLEY) and Europe (CONFIRM). Studies received ethics committee or IRB approvals; all subjects provided written consent. Criteria for both studies included post-menopausal women at high risk of hip fracture with femoral neck T-score≤-2.5. LOEP was performed by preparing and injecting a site in the femoral neck and intertrochanteric area of the proximal femur with a triphasic, resorbable calcium-based implant (AGN1). 72 osteoporotic subjects/85 hips were treated with LOEP as unilateral or bilateral cases. To date, 38 subjects/46 hips has been evaluated with baseline and 2-year aBMD data (COPLEY, 12; CONFIRM, 26). COPLEY evaluated AGN1 implant resorption and replacement with bone utilizing sequential radiographs and computerized tomography (CT) scans at 12 wks, 24 wks and 5-7 years. CONFIRM femoral aBMD was collected at baseline and 2 years.

Results Subjects were aged 69±10 years and a baseline mean±femoral neck T-Score of -2.9±0.4 (N=46). Mean pre-operative FRAX score for 10-year probability of hip fracture was 9.5±8.7% (N=38). Skin-to-skin surgical time was 15±4 minutes (N=34). The mean volume of injection was 17.4±2.5 cc (N=44). Over the course of two-year follow-up, CT and/or radiographs demonstrated complete AGN1 resorption and replacement with bone (N=46). Femoral neck baseline aBMD was 0.62±0.08 g/cm² in CONFIRM and 0.51±0.06 g/cm² in COPLEY. At the 2-year timepoint, mean percent difference in femoral neck aBMD increased by 49%±43% (p<0.001) from baseline (N=45). After surgery all patients were weight bearing to tolerance and mobile within one week. There were nine (9) SAEs reported at two years, none related to study device or procedure (N=46).

Discussion This study demonstrates that treating patients at high risk of femoral fracture due to osteoporotic bone loss with AGN1 LOEP significantly improves aBMD from baseline. This result would be expected to reduce hip fracture risk, which is being evaluated in an ongoing prospective, multi-national, randomized, controlled, single-blinded clinical study. These results support the continued use of AGN1 LOEP for bone loss in the proximal femur.

Keywords LOEP, Proximal Femur, Fracture Risk, Osteoporotic Bone Loss, Clinical Study, Resorbable Implant

Korrespondenzadresse Jo De Schepper, Vitaz , Orthopaedic Department, Prinses Josephine Charlottelaan 21D, 9100 Sint Niklaas, Belgium, E-Mail: [e-mail]

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Artikel online veröffentlicht:
08. September 2022