Clinical trial: Study of AGN1 LOEP to Prevent Secondary Hip Fractures (NCT04796350)

Eligibility criteria:
Inclusion Criteria:

          1. Subject is a postmenopausal female at least 1-year post menses and at least 65 years
             of age.

          2. Subject presents with a low-energy index fragility hip fracture in one hip and will
             undergo surgical repair of the fractured hip.

          3. Subject has at least one of the following additional risk factors for a secondary hip
             fracture (as determined by subject or legally authorized representative (LAR)
             interview or medical record review):

               -  Documented falls assessment indicating subject is at moderate or high risk of
                  falls

               -  Falls history (2 or more falls in the previous 12 months)

               -  History of vertigo, dizziness, or postural hypotension

               -  Documented T-score < -2.5 at the hip

               -  Taking more than 3 daily prescription medications

               -  Visual impairment as confirmed by one of the following:

                    -  Subject reports difficulty seeing

                    -  Lack of depth perception or vision loss in one eye

                    -  Macular degeneration

                    -  Cataracts

               -  Prior non-hip fragility fracture

               -  Cognitive frailty as assessed by SPMSQ (mild or moderate cognitive impairment) or
                  delirium

               -  Parkinson's disease stage 3 or 4

               -  10-year hip fracture probability >15% using the FRAX® Fracture Risk Assessment
                  Tool of the clinical site country

          4. Subject is expected to be ambulatory after the hip fracture repair procedure.

          5. Informed consent is provided by the subject or the subject's LAR.

          6. The subject's willingness, ability, and commitment to participate in screening,
             treatment, and all follow-up evaluations for the full duration of the study has been
             documented.

        Exclusion Criteria:

          1. Subject hospital admission is > 24 hours from the time of the index hip fracture.

          2. Subject was dependent on the use of a wheelchair or was bedridden prior to the index
             hip fracture.

          3. Subject is currently enrolled in another clinical study.

          4. Subject has a history of hip surgery or previous hip fracture on the target
             unfractured hip contralateral to the index hip fracture.

          5. Subject has one or more new fractures in addition to the index hip fracture at
             admission.

          6. Subject has an infection at the LOEP intended treatment site or has non-intact skin or
             acute traumatic injuries with open wounds close to the area of intended LOEP
             treatment.

          7. Subject has a progressive increase in undiagnosed pain in the target hip contralateral
             to the index fractured hip over the previous 3 months that in the opinion of the
             Investigator may suggest underlying bone or joint pathology on the unfractured side.

          8. 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.

          9. Subject is at ASA Class IV, V, or VI.

         10. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's
             disease, renal osteodystrophy, or osteomalacia).

         11. Subject has a history of Pott's disease.

         12. Subject has a history of any invasive malignancy (except nonmelanoma skin cancer),
             unless treated with curative intent and with no clinical signs or symptoms of the
             malignancy for 5 years.

         13. Subject has chronic cardiac insufficiency or severe cardiovascular disease as assessed
             by a subject or LAR interview to be NYHA Class III or IV or has an implanted
             pacemaker.

         14. Subject has a history of cardiovascular events (e.g. stroke, transient ischemic
             attack, myocardial infarction, unstable angina, pulmonary embolus, deep vein
             thrombosis, ventricular tachycardia, or atrial fibrillation) in the last 3 months.

         15. Subject is on oral or parenteral immuno-suppressive drugs.

         16. Subject has uncontrolled diabetes mellitus.

         17. Subject has Hb ≤ 10 g/dL at admission.

         18. Subject has severe renal insufficiency defined as an estimated glomerular filtration
             rate (eGFR) ≤ 30 mL/min.

         19. Subject has albumin corrected serum calcium levels outside the normal laboratory range
             or has a pre-existing calcium metabolism disorder (e.g. hypercalcemia).

         20. Subject has a Parker Mobility Score ≤ 5.

         21. Subject has severe cognitive impairment as assessed by SPMSQ.

         22. Subject has known allergies to calcium-based bone void fillers.

         23. 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).

         24. Subject fails pre-operative or intraoperative eligibility criteria as specified in
             section 7.4.2. of the clinical investigation plan.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.


Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman

Does the patient match the trial criteria? 0