NCT05202678 RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
| NCT ID | NCT05202678 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AgNovos Healthcare, LLC |
| Condition | Osteoporosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-07-05 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2021-07-05 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Jo De Schepper, MD
PRINCIPAL INVESTIGATOR
AZ Nikolaas
Frequently Asked Questions
Who can join the NCT05202678 clinical trial?
This trial is open to female participants only, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05202678 currently recruiting?
Yes, NCT05202678 is actively recruiting participants. Contact the research team at info@agnovos.com for enrollment information.
Where is the NCT05202678 trial being conducted?
This trial is being conducted at Sint-Niklaas, Belgium.
Who is sponsoring the NCT05202678 clinical trial?
NCT05202678 is sponsored by AgNovos Healthcare, LLC. The principal investigator is Jo De Schepper, MD at AZ Nikolaas. The trial plans to enroll 150 participants.