RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis

NCT05202678 | Recruiting

• 1 other identifier: AGN-CIP-301
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Total Hip Bone Mineral Density

  12 months

• Femoral Neck Bone Mineral Density

  24 months

• Total Hip Bone Mineral Density

  24 months

Other Outcomes (12)

• Bone Formation

  12 and 24 months

• Patient Satisfaction

  42 days and 12 months

• Pain hip

  baseline, 42 days, 12 months, and 24 months.

Study Arms (1)

AGN1 LOEP

OTHER

Subjects treated with AGN1 LOEP in proximal femur

Device: AGN1 LOEP

Interventions

AGN1 LOEP DEVICE

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

AGN1 LOEP

Eligibility Criteria

• Gender Eligibility Details: Postmenopausal female with a femoral neck T-score of 2.5 or less
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AgNovos Healthcare, LLC: lead

Study Sites (1)

AZ Nikolaas

Sint-Niklaas, Antwerpen, 9100, Belgium

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Hip Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Jo De Schepper, MD

  AZ Nikolaas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Lowe

CONTACT

+1 240 753 6500; info@agnovos.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: January 21, 2022
• Study Start: July 5, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)