RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis

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.

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).
• Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min or is being treated with dialysis.
• Subject has hemoglobin A1c level ≥ 7.5%.
• Subject has Body Mass Index (BMI) > 35.
• Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator*.
• Subject is at ASA Class III, IV, V or VI.
• Subject exhibits excessive alcohol consumption as determined by the principal investigator*.
• 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/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 immunesuppressive 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 or symptoms of the malignancy for five (5) years.
• Subject has known allergies to implanted device.
• 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/mental health, or drug or alcohol abuse issues).
• Subject is currently enrolled in another clinical study. *AgNovos's recommendation is >1 pack per day smoking and >3 alcoholic drinks per day