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.
Who can participate
Age range65 Years
SexFEMALE
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Inclusion criteria
✓. 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):
✓. 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 criteria
✕. 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.
What they're measuring
1
Cumulative incidence of secondary fragility hip fractures
Timeframe: Interim Analysis, approximately 30 Months
2
Cumulative Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Interim Analysis, approximately 30 Months
✕. 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.