RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

NCT04796350 | Recruiting DMC

• 1 other identifier: AGN-CIP-100 / AGN-CIP-100-CA
• Study Type: interventional
• Target: 2,400
• Locations: 10 countries
• Sites: 54

Brief 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

Fragility Fracture; Hip Fractures; Osteoporosis

Keywords

Osteoporosis; Hip Fracture; Fragility Fracture; LOEP; RESTORE; Local osteo-enhancement procedure

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Interim Analysis, approximately 30 Months

Secondary Outcomes (2)

• Areal bone mineral density (aBMD)

  12 months and 24 months

• Trabecular Bone Score (TBS)

  12 months and 24 months

Study Arms (2)

Treated group

EXPERIMENTAL

Subject receives standard of care to repair the index hip fracture and AGN1 LOEP treatment on the target unfractured contralateral hip

Device: AGN1 LOEP treatment

Control group

NO INTERVENTION

Subject receives standard of care to repair the index hip fracture and no AGN1 LOEP treatment on the target unfractured contralateral hip

Interventions

AGN1 LOEP treatment DEVICE

the implantation site is injected with the AGN1 implant material

Treated group

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Subject is a postmenopausal female at least 1-year post menses and at least 65 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.
• Subject has at least one of the following additional risk factors for a secondary hip fracture (as determined by subject or legally authorized representative (LAR) interview or medical record review):
• Documented falls assessment indicating subject is at moderate or high risk of falls
• Falls history (2 or more falls in the previous 12 months)
• History of vertigo, dizziness, or postural hypotension
• Documented T-score \< -2.5 at the hip
• Taking more than 3 daily prescription medications
• Visual impairment as confirmed by one of the following:
• Subject reports difficulty seeing
• Lack of depth perception or vision loss in one eye
• Macular degeneration
• Cataracts
• Prior non-hip fragility fracture
• Cognitive frailty as assessed by SPMSQ (mild or moderate cognitive impairment) or delirium

You may not qualify if:

• Subject hospital admission is \> 24 hours from the time of the index hip fracture.
• Subject was dependent on the use of a wheelchair or was bedridden prior to the index hip fracture.
• Subject is currently enrolled in another clinical study.
• Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture.
• Subject has one or more new fractures in addition to the index hip fracture at admission that, in the opinion of the investigator, would further compromise patient mobility, rehabilitation, and/or recovery or subject has three or more new fractures in addition to the index hip fracture.
• Subject has an infection at the LOEP intended treatment site or has non-intact skin or acute traumatic injuries with open wounds close to the area of intended LOEP treatment.
• Subject has a progressive increase in undiagnosed pain in the target hip contralateral to the index fractured hip over the previous 3 months that in the opinion of the Investigator may suggest underlying bone or joint pathology on the unfractured side.
• Subject has radiological evidence of gross bony or joint pathology of the hip, including signs predictive of atypical femoral fractures (e.g. cortical beaking), or has been diagnosed and/or treated for atypical femoral fractures.
• Subject is at ASA Class IV, V, or VI.
• Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
• Subject has a history of Pott's disease.
• Subject has a history of any invasive malignancy (except nonmelanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years.
• Subject has chronic cardiac insufficiency or severe cardiovascular disease as assessed by a subject or LAR interview to be NYHA Class III or IV or has an implanted pacemaker.
• Subject has a history of cardiovascular events (e.g. stroke, transient ischemic attack, myocardial infarction, unstable angina, pulmonary embolus, deep vein thrombosis, ventricular tachycardia, or atrial fibrillation) in the last 3 months.
• Subject is on oral or parenteral immuno-suppressive drugs.

Sponsors & Collaborators

• AgNovos Healthcare, LLC: lead
• Avania: collaborator
• CMIC Co, Ltd. Japan: collaborator
• BioClinica, Inc.: collaborator
• Emergent Clinical Consulting, LLC: collaborator

Study Sites (54)

Innsbruck Hospital

Innsbruck, Austria

RECRUITING

Health Sciences Centre - Eastern Health

St. John's, Newfoundland and Labrador, Canada

RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

CHU Grenoble-Alpes

Grenoble, France

RECRUITING

CHU Lyon

Lyon, France

RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

University Hospital of Duesseldorf

Düsseldorf, Germany

RECRUITING

Justus Liebig Universitat Gießen

Giessen, Germany

TERMINATED

Medizinische Hochschule Hannover

Hanover, Germany

RECRUITING

Universitatsklinikum Schleswig-Holstein

Kiel, Germany

RECRUITING

Klinikum der Universität München

München, Germany

RECRUITING

University Hospital of Münster

Münster, Germany

TERMINATED

Universitätsklinikum Regensburg

Regensburg, Germany

RECRUITING

BG Klinik Tuebingen

Tübingen, Germany

RECRUITING

Helios Wuppertal

Wuppertal, Germany

RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

RECRUITING

ASST Gaetano Pini CTO

Milan, Italy

RECRUITING

University Hospital San Raffaele Milano

Milan, Italy

RECRUITING

Policlinico Tor Vergata

Rome, Italy

RECRUITING

CTO Torino

Torino, Italy

RECRUITING

Akita City Hospital

Akita, Akita, Japan

RECRUITING

Southern Tohoku General Hospital

Kōriyama, Fukushima, Japan

RECRUITING

Hyogo Prefectural Nishinomiya Hospital

Nishinomiya, Hyōgo, Japan

RECRUITING

Kagawa Rosai Hospital

Marugame, Kagawa-ken, Japan

RECRUITING

Kanto Rosai Hospital

Kawasaki, Kanagawa, Japan

RECRUITING

Shin-yurigaoka General Hospital

Kawasaki-Shi, Kanagawa, Japan

RECRUITING

Chikamori Hospital

Kochi, Kochi, Japan

RECRUITING

Okayama Medical Center

Okayama, Okayama-ken, Japan

RECRUITING

Jutendo University Shizuoka Hospital

Izunokuni, Shizuoka, Japan

TERMINATED

The University of Tokyo Hospital

Bunkyō-Ku, Tokyo, Japan

RECRUITING

St. Mary's Hospital

Fukuoka, Japan

RECRUITING

Iwata City Hospital

Iwata, Japan

RECRUITING

Shin-Yurigaoka General Hospital

Kawasaki-shi, Japan

RECRUITING

National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan

RECRUITING

Saga-Ken Medical Centre Koseikan

Saga, Japan

RECRUITING

Japanese Red Cross Shizuoka Hospital

Shizuoka, Japan

RECRUITING

Deventer Hospital

Deventer, Netherlands

RECRUITING

Saint Anna Ziekenhuis

Geldrop, Netherlands

TERMINATED

Maastricht UMC

Maastricht, Netherlands

RECRUITING

Isala Hospital

Zwolle, Netherlands

RECRUITING

Vall d'Hebron University Hospital

Barcelona, Barcelona, 08035, Spain

RECRUITING

Valladolid University Clinic Hospital

Valladolid, Valladolid, 47003, Spain

RECRUITING

Clinic de Barcelona

Barcelona, Spain

RECRUITING

Hospital Universitario de Basurto

Bilbao, Spain

RECRUITING

Galdakao-Usansolo Hospital

Galdakao, Spain

RECRUITING

Hospital Neuro-Traumatológico de Jaén

Jaén, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

PARC Tauli

Sabadell, Spain

RECRUITING

Mutua de Terrassa University Hospital

Terrassa, Spain

RECRUITING

Birmingham Heartlands Hospital

Birmingham, England, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, England, United Kingdom

RECRUITING

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

RECRUITING

Nottingham University Hospitals, Queen's Medical Center

Nottingham, United Kingdom

RECRUITING

Related Links

• Japan Registry of Clinical Trials

MeSH Terms

Conditions

Hip Fractures; Osteoporosis

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Charles Raymond

CONTACT

240-753-6421; restore@agnovos.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 12, 2021
• Study Start: April 24, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); DK (1); NL (4); IT (5); AU (1); DE (9); CA (1); ES (10); GB (4); JP (16)