Clinical Trial

RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

Recruiting
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Summary
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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2021-03-11; most recent amendment 2026-05-11.
Status change: Not Yet Recruiting → Recruiting 2021-05-10
Trial Details
NCT Number NCT04796350
Lead Sponsor AgNovos Healthcare, LLC
Collaborators: Avania, CMIC Co, Ltd. Japan, BioClinica, Inc., Emergent Clinical Consulting, LLC
Conditions Fragility Fracture, Hip Fractures, Osteoporosis
Enrollment 2,400 participants
Start Date 2021-04-24
Primary Completion 2027-04-01 (estimated)
Study Completion 2029-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-13