Actively Recruiting
RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
Led by AgNovos Healthcare, LLC · Updated on 2025-01-31
150
Participants Needed
1
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 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 will not qualify if you...
- 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 months suggesting moderate to severe arthritis, labral tear, soft tissue injury, referred pain, tumor, stress fracture, or infection.
- Subject is dependent on the use of a wheelchair or is bedridden.
- Subject has abnormal serum calcium levels or a calcium metabolism disorder.
- Subject has severe kidney failure with eGFR less than 30 mL/min or is on dialysis.
- Subject has hemoglobin A1c level of 7.5% or higher.
- Subject has Body Mass Index (BMI) over 35.
- Subject uses excessive smokeless tobacco or smokes more than 1 pack per day.
- Subject is classified as ASA Class III or higher.
- Subject consumes excessive alcohol (more than 3 drinks per day).
- Subject has major hip bone or joint disease, including atypical femoral fractures.
- Subject has used corticosteroids or systemic glucocorticoids for 10 days or more in the past 6 months.
- Subject has used immune-suppressive drugs in the past 12 months.
- Subject has metabolic bone disease other than osteoporosis.
- Subject has autoimmune arthritic diseases like rheumatoid or psoriatic arthritis.
- Subject has had radiation therapy to the hip or pelvis.
- Subject has a history of invasive cancer unless disease-free for 5 years.
- Subject has allergies to implanted devices.
- Subject is judged not a good candidate due to health, follow-up issues, or substance abuse.
- Subject is currently enrolled in another clinical study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
AZ Nikolaas
Sint-Niklaas, Antwerpen, Belgium, 9100
Actively Recruiting
Research Team
A
Adam Lowe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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