RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis
• Intervention / Treatment: Device: AGN1 LOEP

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Lowe; Phone Number: +1 240 753 6500; Email: info@agnovos.com

Study Locations

• Belgium
  • Antwerpen
    • Sint-Niklaas, Antwerpen, Belgium, 9100
      • Recruiting
      • AZ Nikolaas
      • Contact: Jo De Schepper, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AGN1 LOEP; Subjects treated with AGN1 LOEP in proximal femur	Device: AGN1 LOEP; Subjects with osteoporosis are treated with AGN1 local osteo-enhancement procedure in the proximal femur

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Femoral Neck Bone Mineral Density	6% increase in mean femoral neck BMD from preprocedure baseline to 12 months post-procedure of treated hips	12 months
Primary Safety Evaluation	The incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP through the 12 months follow-up period determined to be at least possibly related to the procedure and/or device.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Hip Bone Mineral Density	6% increase in mean total hip BMD from preprocedure baseline to 12 months post-procedure of treated hips.	12 months
Femoral Neck Bone Mineral Density	6% increase in mean femoral neck BMD from preprocedure baseline to 24 months post-procedure of treated hips.	24 months
Total Hip Bone Mineral Density	6% increase in mean total hip BMD from preprocedure baseline to 24 months post-procedure of treated hips.	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Formation	Radiologic appearance of bone formation as assessed by X-ray at 12 and 24 months post-procedure of treated hips.	12 and 24 months
Patient Satisfaction	Patient satisfaction with outcome of surgery in the treated hip(s) and overall at 42 days and 12 months assessed with Visual Analogue Scale.	42 days and 12 months
Pain hip	Pain (left hip, right hip) at baseline, 42 days, 12 months, and 24 months assessed with Visual Analogue Scale.	baseline, 42 days, 12 months, and 24 months.
Pain body overall	Pain body overall at baseline, 42 days, 12 months, and 24 months assessed with Visual Analogue Scale.	baseline, 42 days, 12 months, and 24 months.
FES-I	FES-I at baseline, 42 days, 12 months, and 24 months	baseline, 42 days, 12 months, and 24 months
Quality of Life with EQ5D-5L	EQ5D-5L at baseline, 10 days, 42 days, 12 months, and 24 months	baseline, 10 days, 42 days, 12 months, and 24 months
Parker Mobility Score	Parker Mobility Score at baseline, 10 days, 42 days, 12 months, and 24 months.	baseline, 10 days, 42 days, 12 months, and 24 months.
Verifying the enhancement site	The ability to access the enhancement site by drilling through the lateral femoral cortex of the proximal femur and to determine the boundaries of the enhancement site using the probe debrider.	Procedure (day 0)
Technical Success	The ability to deliver the necessary amount of AGN1 material to adequately fill the osseous defect as assessed by the treating surgeon.	Procedure (day 0)
SAE	Incidence of all serious adverse events post-AGN1 LOEP through the 24 months follow-up period.	24 months
Hip Fracture	Incidence of new hip fractures on the treated side.	24 months
Timed up and go test	Timed up and go test at baseline, 10 days, 42 days and 12 months.	baseline, 10 days, 42 days and 12 months.

Collaborators and Investigators

• Sponsor: AgNovos Healthcare, LLC
• Investigators: Principal Investigator: Jo De Schepper, MD, AZ Nikolaas

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: LOEP; Bone mineral density; proximal femur; Hip fracture; Femoral strength; Local osteo-enhancement procedure; RECONFIRM
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: AGN-CIP-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No