[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AgNovos Healthcare, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":103},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100638596","grace-ii-general-retrospective-analysis-of-commercial-experience-with-agn1-loep-100638596",false,"NCT07594639","GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)","Retrospective Study of OSSURE LOEP in Osteopenic and Osteoporotic Subjects in the Commercial European Market","Inclusion Criteria:\n\n* Subject has previously received AGN1 LOEP treatment in the proximal femur after September 2019 and before January 2026.\n* Subject can give written informed consent to allow for data collection. Obtaining informed consent is not required for deceased subjects.\n\nExclusion Criteria:\n\n-The subject's AGN1 LOEP treatment was previously performed as part of an AgNovos prior protocoled clinical study.","ALL",{"count":18,"type":19},305,"ESTIMATED","OBSERVATIONAL","The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated between September 2019 and January 2026. Subjects treated as part of an AgNovos prior protocoled study are excluded. Investigators are asked to reach out to all subjects that were previously treated with the AGN1 LOEP Kit in the proximal femur. Subject informed consent is obtained before a subject is enrolled into the study. Subjects treated but not enrolled are documented in a log with the reason why a subject did not participate. This log is kept on site. Enrolled subjects will be contacted per telephone to collect information about any fractures sustained post-AGN1 LOEP treatment.",[23],"Osteoporosis",[25,26,27,28,29,30,31,32,33,34],"Bone mineral density","Femoral strength","Hip fracture","Local osteo-enhancement procedure","LOEP","Proximal femur","Osteogenesis Imperfecta","OI","Hypophosphatasia","HPP","NOT_YET_RECRUITING","2026-05-15",{"date":38,"type":39},"2026-05-19","ACTUAL",{"date":41,"type":19},"2026-06-01",{"date":43,"type":19},"2026-09-30",{"name":45,"class":46},"AgNovos Healthcare, LLC","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100423628","restore---study-of-agn1-loep-to-prevent-secondary-hip-fractures-100423628","NCT04796350","RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures","Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures","Inclusion Criteria:\n\n1. Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age and less than 92 years of age.\n2. Subject presents with a low-energy index fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.\n3. Subject has at least one of the following additional risk factors for a secondary hip fracture (as determined by subject or legally authorized representative (LAR) interview or medical record review):\n\n   * Documented falls assessment indicating subject is at moderate or high risk of falls\n   * Falls history (2 or more falls in the previous 12 months)\n   * History of vertigo, dizziness, or postural hypotension\n   * Documented T-score \\\u003C -2.5 at the hip\n   * Taking more than 3 daily prescription medications\n   * Visual impairment as confirmed by one of the following:\n\n     * Subject reports difficulty seeing\n     * Lack of depth perception or vision loss in one eye\n     * Macular degeneration\n     * Cataracts\n   * Prior non-hip fragility fracture\n   * Cognitive frailty as assessed by SPMSQ (mild cognitive impairment determined by SPMSQ ≤ to 4) or delirium\n   * Parkinson's disease stage 3 or 4\n   * 10-year hip fracture probability \\>15% using the FRAX® Fracture Risk Assessment Tool of the clinical site country\n4. Subject is expected to be ambulatory after the hip fracture repair procedure. \"Ambulatory\" is defined as a patient's ability to ambulate beyond simple transfers with or without assistive devices.\n5. Informed consent is provided by the subject or the subject's LAR. Use of an LAR to obtain patient consent requires that the patient must understand and be able to participate in post operative restrictions and requirements.\n6. The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full duration of the study has been documented.\n\nExclusion Criteria:\n\n1. Criterion omitted\n2. Criterion omitted\n3. Subject is currently enrolled in another interventional clinical study affecting the target hip.\n4. Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture.\n5. Subject has new fractures in addition to the index hip fracture at admission that, in the opinion of the investigator, would further compromise patient mobility, rehabilitation, or recovery.\n6. Subject has an infection at the LOEP intended treatment site or has non-intact skin or acute traumatic injuries with open wounds close to the area of intended LOEP treatment.\n7. Subject has a progressive increase in undiagnosed pain in the target hip contralateral to the index fractured hip over the previous 3 months that in the opinion of the Investigator may suggest underlying bone or joint pathology on the unfractured side.\n8. Subject has radiological evidence of gross bony or joint pathology of the hip, including signs predictive of atypical femoral fractures (e.g. cortical beaking), or has been diagnosed and\u002For treated for atypical femoral fractures.\n9. Criterion omitted\n10. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).\n11. Criterion omitted\n12. Subject has active cancer\n13. Criterion omitted\n14. Criterion omitted\n15. Criterion omitted\n16. Criterion omitted\n17. Criterion omitted\n18. Subject has end stage renal insufficiency defined as an estimated glomerular filtration rate (eGFR) \\\u003C 15 mL\u002Fmin.\n19. Criterion omitted\n20. Criterion omitted\n21. Subject has moderate or severe cognitive impairment as assessed by an SPMSQ of 5 or higher.\n22. Subject has known allergies to calcium-based bone void fillers.\n23. In the judgement of the Investigator, the subject is not a good study candidate (e.g., poor mental health, or active drug or alcohol abuse issues), and or subject would not be a good candidate to undergo an ELECTIVE orthopedic surgical procedure such as a total hip arthroplasty in her current medical, physiological condition.\n24. Subject fails pre-operative or intraoperative eligibility criteria as specified in section 7.4.2. of the clinical investigation plan.","FEMALE","65 Years","91 Years",{"count":59,"type":19},2400,"INTERVENTIONAL",[62],"NA","A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures. Up to 2400 subjects will be randomized between a treatment group and a control group. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.",[65,66,23],"Fragility Fracture","Hip Fractures",[23,68,65,29,69,28],"Hip Fracture","RESTORE","RECRUITING","2026-05-11",{"date":73,"type":39},"2026-05-13",{"date":75,"type":39},"2021-04-24",{"date":77,"type":19},"2029-04-01",{"name":45,"class":46},66,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":55,"minAge":4,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":60,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":47},"100454833","reconfirm---study-of-agn1-loep-in-patients-with-osteoporosis-100454833","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","Inclusion Criteria:\n\n1. Subject is a postmenopausal female (at least 1-year post menses).\n2. Subject has bone loss in the hip attributable to osteoporosis as defined by a femoral neck DXA T-score of -2.5 or less.\n3. Subject has at least one hip without previous surgery or fracture.\n4. 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.\n5. Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.\n6. Subject is capable of giving written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Subject is less than 3 months removed from having a hip fracture repair or prosthesis or elective Total Hip Arthroplasty (THA).\n2. 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.\n3. Subject is dependent on the use of a wheelchair or is bedridden.\n4. Subject has albumin corrected serum calcium levels outside the normal lab range or has a pre-existing calcium metabolism disorder (e.g., hypercalcemia).\n5. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin or is being treated with dialysis.\n6. Subject has hemoglobin A1c level ≥ 7.5%.\n7. Subject has Body Mass Index (BMI) \\> 35.\n8. Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator\\*.\n9. Subject is at ASA Class III, IV, V or VI.\n10. Subject exhibits excessive alcohol consumption as determined by the principal investigator\\*.\n11. Subject has radiological evidence of gross bony or joint pathology of the hip, including signs predictive of atypical femoral fractures (e.g., Cortical beaking) or has been diagnosed and\u002For treated for atypical femoral fractures.\n12. Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in the previous six (6) months.\n13. Subject has history of oral or parenteral use of immunesuppressive drugs in the previous twelve months.\n14. Subject has history of metabolic bone disease other than osteoporosis (ex. Paget's disease).\n15. Subject has a history of auto-immune arthritic diseases including rheumatoid, psoriatic, or those associated with systemic lupus erythematosus, spondyloarthropathy, Reiter's Syndrome or Crohn's Disease.\n16. Subject has a history of radiation therapy to the hip or pelvic region.\n17. Subject has a history of any invasive malignancy (except basal cell carcinoma), unless treated and with no clinical signs or symptoms of the malignancy for five (5) years.\n18. Subject has known allergies to implanted device.\n19. In the judgement of the Investigator, the subject is not a good study candidate (e.g., inability to maintain follow-up schedule, comorbidity or poor general physical\u002Fmental health, or drug or alcohol abuse issues).\n20. Subject is currently enrolled in another clinical study. \\*AgNovos's recommendation is \\>1 pack per day smoking and \\>3 alcoholic drinks per day",{"count":88,"type":19},150,[62],"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.",[23],[25,26,27,28,29,93,94],"proximal femur","RECONFIRM","2025-01-29",{"date":97,"type":39},"2025-01-31",{"date":99,"type":39},"2021-07-05",{"date":101,"type":19},"2026-12",{"name":45,"class":46},""]