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RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

NCT04796350 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

AGN1 LOEP treatment

the implantation site is injected with the AGN1 implant material

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • CMIC Co, Ltd. Japan

    collaborator INDUSTRY

  • BioClinica, Inc.

    collaborator INDUSTRY

  • Emergent Clinical Consulting, LLC

    collaborator INDUSTRY

  • AgNovos Healthcare, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
91 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-24
Primary Completion
2027-04-01
Completion
2029-04-01

Countries

  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04796350 on ClinicalTrials.gov