Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures
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 treatment group and a control group. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.
• 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.