RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age65-91
SponsorAgNovos Healthcare, LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age and less than 92 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.
Documented falls assessment indicating subject is at moderate or high risk of falls
Falls history (2 or more falls in the previous 12 months)
Disqualifiers
Criterion omitted
Criterion omitted
Subject is currently enrolled in another interventional clinical study affecting the target hip.
Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture.
Trial design
Design model
Parallel
Treatments tested in this trial
AGN1 LOEP treatment
Devicethe implantation site is injected with the AGN1 implant material
Treatment groups
2,400 Participants
are divided into 2 treatment groupsGroup A: Treated groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 Months2
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 MonthsSecondary outcomes
1
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
AgNovos Healthcare, LLC
Lead sponsor
Avania
Collaborator
CMIC Co, Ltd. Japan
Collaborator
BioClinica, Inc.
Collaborator
Emergent Clinical Consulting, LLC
Collaborator
Source ClinicalTrials.gov