CONFIRM - Study of AGN1 LOEP in Patients With Osteoporosis

Study Overview
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Brief Summary
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The study will evaluate the immediate procedure and post-procedure profile of the AGN1 Femoral LOEP™ Kit. All subjects will receive the treatment and be evaluated for any adverse or serious adverse events that could occur during the procedure or immediately post-procedure.

Detailed Description
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This research study will be conducted as a post-CE Mark prospective multi-center study within Europe. In total 60 patients will be treated with the OSSURE LOEP kit. Follow-up visits will be conducted ten (10) and forty-two (42) days after the procedure. In addition, all subjects will have the option to consent for a long term follow-up evaluation at twelve (12) months post-procedure.

Official Title
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Clinical Evaluation of the Safety of a Local Osteo-Enhancement Procedure (LOEP™) Intended to Increase Bone Strength in the Proximal Femur of Women in Europe With Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Device: AGN1 Femoral Local Osteo-Enhancement Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is postmenopausal female (at least 1-year post menses). Subject has osteoporosis as defined by a documented DXA scan T score of ≤ -2.5 in the femoral neck of at least one hip within the last year. If no documented T-score, then a DXA scan will be performed during eligibility screening. Subject has 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 six (6) months removed from having a hip fracture repair or prosthesis, or less than three (3) months removed from an elective THA. Subject has progressive increase in undiagnosed hip pain over the previous six months that in the opinion of the Investigator may suggest other underlying bone or joint pathology (e.g. rheumatoid arthritis, fracture, etc.). Subject is dependent on the use of a wheel-chair or is bed-ridden. Subject has albumin corrected serum calcium levels outside the normal lab range or has a pre-existing calcium metabolism disorder (e.g. hypercalcemia). Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) ≤ 30 mL/min or is being treated with dialysis. Subject has insulin-dependent diabetes mellitus (IDDM). Subject has Body Mass Index (BMI) > 35. Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator*. Subject exhibits excessive alcohol consumption as determined by the principal investigator*. Subject has radiological evidence of gross bony or joint pathology, including signs predictive of atypical femoral fractures (e.g. Cortical beaking) or has been diagnosed and/or treated for atypical femoral fractures. Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in the previous six (6) months. Subject has history of oral or parenteral use of immune-suppressive drugs in the previous twelve months. Subject has history of metabolic bone disease other than osteoporosis (ex. Paget's disease). 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. Subject has a history of radiation therapy to the hip or pelvic region. Subject has a history of any invasive malignancy (except basal cell carcinoma), unless treated and with no clinical signs of symptoms of malignancy for five (5) years. Subject has known allergies to implanted device. Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate. Subject is currently enrolled in another clinical study. *AgNovos's recommendation is >1 pack per day smoking and >3 alcoholic drinks per day
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>All subjects who meet the inclusion and exclusion criteria will receive the AGN1 Femoral Local Osteo-Enhancement Procedure (LOEP™) treatment | Device: AGN1 Femoral Local Osteo-Enhancement Procedure<br>* A procedure that is intended to increase the strength of the proximal femur in individuals with osteoporosis of the femoral neck. Local treatment of the proximal femur with AGN1 is intended to be adjunctive to appropriate systemic therapy and overall osteoporosis management as directed by the patient's treating physicians.<br>* Other names: AGN1 Femoral LOEP™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with procedure-related or device-related adverse events | Adverse Events and Serious Adverse Events related to either the treatment or device. The incidence of all adverse events occurring during the first forty-two (42) day follow-up period determined to be at least possibly related to the procedure and/or device for the local treatment of osteoporosis. | 42 Days |