Clinical trial NCT05202678: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoporosis
Keywords: Bone mineral density
Femoral strength
Hip fracture
Local osteo-enhancement procedure
LOEP
proximal femur
RECONFIRM
Lead sponsor: AgNovos Healthcare, LLC
Sponsor class: INDUSTRY
First posted: 2022-01-21
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Femoral Neck Bone Mineral Density
timeFrame: 12 months
measure: Primary Safety Evaluation
timeFrame: 12 months
Secondary outcomes:
measure: Total Hip Bone Mineral Density
timeFrame: 12 months
measure: Femoral Neck Bone Mineral Density
timeFrame: 24 months
measure: Total Hip Bone Mineral Density
timeFrame: 24 months
Other outcomes:
measure: Bone Formation
timeFrame: 12 and 24 months
measure: Patient Satisfaction
timeFrame: 42 days and 12 months
measure: Pain hip
timeFrame: baseline, 42 days, 12 months, and 24 months.
measure: Pain body overall
timeFrame: baseline, 42 days, 12 months, and 24 months.
measure: FES-I
timeFrame: baseline, 42 days, 12 months, and 24 months
measure: Quality of Life with EQ5D-5L
timeFrame: baseline, 10 days, 42 days, 12 months, and 24 months
measure: Parker Mobility Score
timeFrame: baseline, 10 days, 42 days, 12 months, and 24 months.
measure: Verifying the enhancement site
timeFrame: Procedure (day 0)
measure: Technical Success
timeFrame: Procedure (day 0)
measure: SAE
timeFrame: 24 months
measure: Hip Fracture
timeFrame: 24 months
measure: Timed up and go test
timeFrame: baseline, 10 days, 42 days and 12 months.
Locations:
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
state: Antwerpen
Study officials:
affiliation: AZ Nikolaas
name: Jo De Schepper, MD
role: PRINCIPAL_INVESTIGATOR
References: