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
Qualifiers
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
Treatments tested in this trial
- AGN1 LOEP treatment
Treatment groups
2,400 Participants
are divided into 2 treatment groupsSponsors and collaborators
AgNovos Healthcare, LLC
Lead sponsor
Avania
Collaborator
CMIC Co, Ltd. Japan
Collaborator
BioClinica, Inc.
Collaborator
Emergent Clinical Consulting, LLC
Collaborator
Source ClinicalTrials.gov