RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device AGN1 LOEP
  Subjects with osteoporosis are treated with AGN1 local osteo-enhancement procedure in the proximal femur

Primary outcome measures

• Femoral Neck Bone Mineral Density [Time frame: 12 months]
• Primary Safety Evaluation [Time frame: 12 months]

Secondary outcome measures (3)

• Total Hip Bone Mineral Density [Time frame: 12 months]
• Femoral Neck Bone Mineral Density [Time frame: 24 months]
• Total Hip Bone Mineral Density [Time frame: 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Belgium · 1 center

• AZ Nikolaas — Sint-Niklaas

Identifiers

NCT: NCT05202678 · AGN-CIP-301

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗