Study of AGN1 LOEP to Prevent Secondary Hip Fractures

JRCT ID: jRCT2022210008

Registered date:03/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Osteoporotic female presenting with initial proximal femur fracture and undergoing fracture repair
• Date of first enrollment: 24/04/2021
• Target sample size: 2400
• Countries of recruitment: Germany,Japan,The Netherlands,Japan,Spain,Japan,Austria,Japan,United Kingdom,Japan
• Study type: Interventional
• Intervention(s): Patient receives standard of care to repair the index hip fracture and AGN1 LOEP treatment on the target unfractured contralateral hip if randomized to treatment group

Outcome(s)

• Primary Outcome: The cumulative incidence of secondary fragility hip fractures in the contralateral unfractured target hip

Secondary Outcome

Total hip areal bone mineral density (aBMD) at 1 year
Total hip areal bone mineral density (aBMD) at 2 year
Trabecular Bone Score (TBS) at 1 year
Trabecular Bone Score (TBS) at 2 year

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Female

Include 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 interview, 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 cognitive impairment) or delirium
-Parkinsons 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 subjects legally authorized representative.
6. The subjects willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full duration of the study has been documented.

Exclude 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 nonintact 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., Pagets disease, renal osteodystrophy, or osteomalacia).
11. Subject has a history of tuberculous spondylitis.
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 <= 9 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.

Related Information

• Primary Sponsor: Lowe Adam
• Secondary ID(s): NCT04796350