Using AGN1 LOEP to treat osteoporosis in women

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

This study is testing a new procedure called AGN1 LOEP to see if it can help postmenopausal women with osteoporosis build new bone in their hips.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sex: Female
• Sponsor: AgNovos Healthcare, LLC (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Sint-Niklaas, Antwerpen)
• Trial ID: NCT05202678 on ClinicalTrials.gov

What this trial studies

This research involves a prospective, post-market, multi-center evaluation of AGN1 LOEP, a procedure aimed at forming new bone in the proximal femur of postmenopausal women with osteoporosis. The study will enroll up to 150 participants across 20 sites in Europe and will be non-randomized and open-label. Participants will undergo follow-up evaluations at multiple time points to assess safety, clinical performance, and patient satisfaction. Key assessments will include bone density scans and various health evaluations over a two-year period.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women with osteoporosis and a femoral neck DXA T-score of -2.5 or less who have at least one intact hip.

Not a fit: Patients who have had recent hip surgeries or fractures, or those with severe intra-articular arthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could significantly improve bone density and reduce the risk of hip fractures in women with osteoporosis.

How similar studies have performed: While this approach is innovative, it is based on existing techniques for enhancing bone density, and similar studies have shown promise in improving outcomes for osteoporosis patients.

Eligibility criteria

Inclusion Criteria:

1. Subject is a postmenopausal female (at least 1-year post menses).
2. Subject has bone loss in the hip attributable to osteoporosis as defined by a femoral neck DXA T-score of -2.5 or less.
3. Subject has at least one hip without previous surgery or fracture.
4. 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.
5. Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
6. Subject is capable of giving written informed consent to participate in the study.

Exclusion Criteria:

1. Subject is less than 3 months removed from having a hip fracture repair or prosthesis or elective Total Hip Arthroplasty (THA).
2. 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.
3. Subject is dependent on the use of a wheelchair or is bedridden.
4. Subject has albumin corrected serum calcium levels outside the normal lab range or has a pre-existing calcium metabolism disorder (e.g., hypercalcemia).
5. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min or is being treated with dialysis.
6. Subject has hemoglobin A1c level ≥ 7.5%.
7. Subject has Body Mass Index (BMI) \> 35.
8. Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator\*.
9. Subject is at ASA Class III, IV, V or VI.
10. Subject exhibits excessive alcohol consumption as determined by the principal investigator\*.
11. 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.
12. Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in the previous six (6) months.
13. Subject has history of oral or parenteral use of immunesuppressive drugs in the previous twelve months.
14. Subject has history of metabolic bone disease other than osteoporosis (ex. Paget's disease).
15. 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.
16. Subject has a history of radiation therapy to the hip or pelvic region.
17. 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.
18. Subject has known allergies to implanted device.
19. 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).
20. Subject is currently enrolled in another clinical study. \*AgNovos's recommendation is \>1 pack per day smoking and \>3 alcoholic drinks per day

Where this trial is running

Sint-Niklaas, Antwerpen

• AZ Nikolaas — Sint-Niklaas, Antwerpen, Belgium (Recruiting)

Study contacts

• Principal investigator: Jo De Schepper, MD — AZ Nikolaas
• Study coordinator: Adam Lowe

Conditions Osteoporosis; Bone mineral density; Femoral strength; Hip fracture; Local osteo-enhancement procedure; LOEP; proximal femur; RECONFIRM