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.
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 reduce the incidence of secondary hip fractures in subjects presenting with an index hip fracture and undergoing hip fracture repair surgery. Subjects presenting with an index fragility hip fracture who will undergo hip fracture repair will be enrolled. Subjects will be randomized 1:1 into the following two study groups: 1. Treated Group - receives standard of care to repair the index hip fracture and AGN1 LOEP treatment on the target unfractured contralateral hip 2. Control Group - receives standard of care to repair the index hip fracture and no AGN1 LOEP treatment on the target unfractured contralateral hip AGN1 LOEP is an elective procedure that will be performed immediately following hip fracture repair. Subjects will be followed through scheduled visits conducted at 6 weeks, 6 months, and every 6 months thereafter for a minimum of 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,400
the implantation site is injected with the AGN1 implant material
Cumulative incidence of secondary fragility hip fractures
Comparison of incidence of secondary fragility hip fractures in the target hip among the Treated Group vs. Control Group.
Time frame: Interim Analysis, approximately 30 Months
Cumulative Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Comparison of incidence of AEs and SAEs among the Treated Group vs. Control Group.
Time frame: Interim Analysis, approximately 30 Months
Areal bone mineral density (aBMD)
Total hip areal bone mineral density in target hips of the Treated Group compared to the Control Group
Time frame: 12 months and 24 months
Trabecular Bone Score (TBS)
Continuous densitometry measure of the target hip bone of the Treated Group compared to the Control Group
Time frame: 12 months and 24 months
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Innsbruck Hospital
Innsbruck, Austria
RECRUITINGHealth Sciences Centre - Eastern Health
St. John's, Newfoundland and Labrador, Canada
RECRUITINGAarhus University Hospital
Aarhus, Denmark
RECRUITINGCHU Grenoble-Alpes
Grenoble, France
RECRUITINGCHU Lyon
Lyon, France
RECRUITINGCHU Toulouse
Toulouse, France
RECRUITINGUniversity Hospital of Duesseldorf
Düsseldorf, Germany
RECRUITINGJustus Liebig Universitat Gießen
Giessen, Germany
TERMINATEDMedizinische Hochschule Hannover
Hanover, Germany
RECRUITINGUniversitatsklinikum Schleswig-Holstein
Kiel, Germany
RECRUITING...and 44 more locations