Status:
RECRUITING
RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
Lead Sponsor:
AgNovos Healthcare, LLC
Collaborating Sponsors:
Avania
CMIC Co, Ltd. Japan
Conditions:
Fragility Fracture
Hip Fractures
Eligibility:
FEMALE
65+ years
Phase:
NA
Brief Summary
A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures. Up to 2400 subjects will be randomized between a tr...
Detailed Description
This is an event driven, randomized, controlled, prospective, single blinded (non-blinded in Canada), multi-national study. This study is designed to demonstrate that the AGN1 LOEP treatment can redu...
Eligibility Criteria
Inclusion
- Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age.
- Subject presents with a low-energy index fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.
- 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
- Subject is expected to be ambulatory after the hip fracture repair procedure.
- Informed consent is provided by the subject or the subject's LAR.
- 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
- Subject hospital admission is \> 24 hours from the time of the index hip fracture.
- Subject was dependent on the use of a wheelchair or was bedridden prior to the index hip fracture.
- Subject is currently enrolled in another clinical study.
- Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture.
- Subject has one or more new fractures in addition to the index hip fracture at admission that, in the opinion of the investigator, would further compromise patient mobility, rehabilitation, and/or recovery or subject has three or more new fractures in addition to the index hip fracture.
- 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.
- 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.
- 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 is at ASA Class IV, V, or VI.
- Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
- Subject has a history of Pott's disease.
- 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.
- 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.
- 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.
- Subject is on oral or parenteral immuno-suppressive drugs.
- Subject has uncontrolled diabetes mellitus.
- Subject has Hb ≤ 9 g/dL at admission.
- Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) ≤ 30 mL/min.
- Subject has a diagnosed and ongoing calcium metabolism disorder.
- Subject has a Parker Mobility Score ≤ 5.
- Subject has severe cognitive impairment as assessed by SPMSQ.
- Subject has known allergies to calcium-based bone void fillers.
- 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 fails pre-operative or intraoperative eligibility criteria as specified in section 7.4.2. of the clinical investigation plan.
Key Trial Info
Start Date :
April 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT04796350
Start Date
April 24 2021
End Date
April 1 2029
Last Update
September 16 2025
Active Locations (54)
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1
Innsbruck Hospital
Innsbruck, Austria
2
Health Sciences Centre - Eastern Health
St. John's, Newfoundland and Labrador, Canada
3
Aarhus University Hospital
Aarhus, Denmark
4
CHU Grenoble-Alpes
Grenoble, France