bone weakening osteoporosis
Conditions
Interventions
The medical device is the OSSURE LOEP Kit (i.e., kit for local strengthening of
the proximal (upper) femur, which means hip). Part of this product is a
synthetic (i.e., man-made), calcium-based impl
LOEP
Osteoporosis
Sponsors
AgNovos Healthcare USA, LLC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subject is postmenopausal female (at least 1-year post menses) 2. Subject has osteoporosis as defined by a documented DXA scan T-score of
Exclusion criteria
Exclusion criteria: 1. Subject is less than six (6) months removed from having a hip fracture repair or prosthesis, or less than three (3) months removed from an elective THA. 2. Subject has progressive increase in undiagnosed hip pain over the previous six months that in the opinion of the Investigator may suggest other underlying bone or joint pathology (e.g. rheumatoid arthritis, fracture, etc.). 3. Subject is dependent on the use of a wheel-chair or is bed-ridden. 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) 35. 8. Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator*. 9. Subject exhibits excessive alcohol consumption as determined by the principal investigator*. 10. Subject has radiological evidence of gross bony or joint pathology, including signs predictive of atypical femoral fractures (e.g. Cortical beaking) or has been diagnosed and/or treated for atypical femoral fractures. 11. Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in the previous six (6) months. 12. Subject has history of oral or parenteral use of immune-suppressive drugs in the previous twelve months. 13. Subject has history of metabolic bone disease other than osteoporosis (ex. Paget*s disease). 14. 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. 15. Subject has a history of radiation therapy to the hip or pelvic region. 16. Subject has a history of any invasive malignancy (except basal cell carcinoma), unless treated and with no clinical signs of symptoms of malignancy for five (5) years. 17. Subject has known allergies to implanted device. 18. Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate. 19. Subject is currently enrolled in another clinical study. *AgNovos*s recommendation is >1 pack per day smoking and >3 alcoholic drinks per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of all adverse events occurring during the first forty-two (42) day follow-up period determined to be at least possibly related to the procedure and/or device for the local treatment of osteoporosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| • The ability to deliver the necessary amount of OSSURE material to fill the osseous defect as assessed by the treating doctor. • The ability to access the intended treatment site and successfully inject the material. | — |
Countries
Belgium, Netherlands
Outcome results
None listed