Status:
RECRUITING
RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
Lead Sponsor:
AgNovos Healthcare, LLC
Conditions:
Osteoporosis
Eligibility:
FEMALE
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Subject has a history of radiation therapy to the hip or pelvic region.
- 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.
- Subject has known allergies to implanted device.
- 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).
- Subject is currently enrolled in another clinical study. \*AgNovos's recommendation is \>1 pack per day smoking and \>3 alcoholic drinks per day
Key Trial Info
Start Date :
July 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05202678
Start Date
July 5 2021
End Date
December 1 2026
Last Update
January 31 2025
Active Locations (1)
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1
AZ Nikolaas
Sint-Niklaas, Antwerpen, Belgium, 9100