RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

March 6, 2024 updated by: AgNovos Healthcare, LLC

Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an event driven, randomized, controlled, prospective, single blinded (non-blinded in Canada), multi-national study.

This study is designed to demonstrate that the AGN1 LOEP treatment can reduce the incidence of secondary hip fractures in subjects presenting with an index hip fracture and undergoing hip fracture repair surgery. Subjects presenting with an index fragility hip fracture who will undergo hip fracture repair will be enrolled. Subjects will be randomized 1:1 into the following two study groups:

  1. Treated Group - receives standard of care to repair the index hip fracture and AGN1 LOEP treatment on the target unfractured contralateral hip
  2. Control Group - receives standard of care to repair the index hip fracture and no AGN1 LOEP treatment on the target unfractured contralateral hip

AGN1 LOEP is an elective procedure that will be performed immediately following hip fracture repair.

Subjects will be followed through scheduled visits conducted at 6 weeks, 6 months, and every 6 months thereafter for a minimum of 5 years.

Study Type

Interventional

Enrollment (Estimated)

2400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Innsbruck, Austria
  • Denmark
      • Aarhus, Denmark
  • France
  • Germany
      • Düsseldorf, Germany
        • Recruiting
        • University Hospital of Duesseldorf
        • Contact:
      • Gießen, Germany
        • Recruiting
        • Justus Liebig Universitat Gießen
        • Contact:
      • Hannover, Germany
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
      • Kiel, Germany
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein
        • Contact:
      • München, Germany
        • Recruiting
        • Klinikum der Universität München
        • Contact:
      • Münster, Germany
        • Terminated
        • University Hospital of Münster
      • Regensburg, Germany
        • Recruiting
        • Universitätsklinikum Regensburg
        • Contact:
      • Tuebingen, Germany
  • Italy
      • Firenze, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Careggi
        • Contact:
      • Milano, Italy
      • Milano, Italy
        • Recruiting
        • University Hospital San Raffaele Milano
        • Contact:
      • Rome, Italy
  • Japan
      • Fukuoka, Japan
      • Iwata, Japan
      • Kawasaki-shi, Japan
      • Kumamoto, Japan
        • Recruiting
        • National Hospital Organization Kumamoto Medical Center
        • Contact:
      • Saga, Japan
        • Recruiting
        • Saga-Ken Medical Centre Koseikan
        • Contact:
      • Shizuoka, Japan
        • Recruiting
        • Japanese Red Cross Shizuoka Hospital
        • Contact:
    • Akita
      • Akita-shi, Akita, Japan
    • Fukushima
      • Kōriyama, Fukushima, Japan
        • Recruiting
        • Southern Tohoku General Hospital
        • Contact:
    • Hyogo
      • Nishinomiya, Hyogo, Japan
        • Recruiting
        • Hyogo Prefectural Nishinomiya Hospital
        • Contact:
    • Kagawa
      • Marugame, Kagawa, Japan
    • Kanagawa
      • Kawasaki City, Kanagawa, Japan
      • Kawasaki-Shi, Kanagawa, Japan
    • Kochi
      • Kouchi City, Kochi, Japan
    • Okayama
      • Okayama City, Okayama, Japan
    • Shizuoka
      • Izunokuni City, Shizuoka, Japan
        • Terminated
        • Jutendo University Shizuoka Hospital
    • Tokyo
      • Bunkyō-Ku, Tokyo, Japan
        • Recruiting
        • The University of Tokyo Hospital
        • Contact:
  • Netherlands
      • Deventer, Netherlands
      • Geldrop, Netherlands
        • Terminated
        • Saint Anna Ziekenhuis
      • Maastricht, Netherlands
      • Zwolle, Netherlands
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall d'Hebron University Hospital
        • Contact:
      • Barcelona, Spain
      • Bilbao, Spain
        • Recruiting
        • Hospital Universitario de Basurto
        • Contact:
      • Galdakao, Spain
      • Jaén, Spain
        • Recruiting
        • Hospital Neuro-Traumatológico de Jaén
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain
      • Sabadell, Spain
      • Terrassa, Spain
        • Recruiting
        • Mutua de Terrassa University Hospital
        • Contact:
      • Valladolid, Spain, 47003
        • Recruiting
        • Valladolid University Clinic Hospital
        • Contact:
  • United Kingdom
      • Nottingham, United Kingdom
        • Recruiting
        • Nottingham University Hospitals, Queen's Medical Center
        • Contact:
    • England
      • Birmingham, England, United Kingdom
      • Leicester, England, United Kingdom
    • Scotland
      • Edinburgh, Scotland, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age.
  2. Subject presents with a low-energy index fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.

  3. 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
    • Parkinson's disease stage 3 or 4
    • 10-year hip fracture probability >15% using the FRAX® Fracture Risk Assessment Tool of the clinical site country
  4. Subject is expected to be ambulatory after the hip fracture repair procedure.
  5. Informed consent is provided by the subject or the subject's LAR.
  6. The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full duration of the study has been documented.

Exclusion Criteria:

  1. Subject hospital admission is > 24 hours from the time of the index hip fracture.
  2. Subject was dependent on the use of a wheelchair or was bedridden prior to the index hip fracture.
  3. Subject is currently enrolled in another clinical study.
  4. Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. Subject is at ASA Class IV, V, or VI.
  10. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
  11. Subject has a history of Pott's disease.
  12. 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.
  13. 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.
  14. 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.
  15. Subject is on oral or parenteral immuno-suppressive drugs.
  16. Subject has uncontrolled diabetes mellitus.
  17. Subject has Hb ≤ 9 g/dL at admission.
  18. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) ≤ 30 mL/min.
  19. Subject has a diagnosed and ongoing calcium metabolism disorder.
  20. Subject has a Parker Mobility Score ≤ 5.
  21. Subject has severe cognitive impairment as assessed by SPMSQ.
  22. Subject has known allergies to calcium-based bone void fillers.
  23. In the judgement of the Investigator, the subject is not a good study candidate (e.g., inability to maintain follow-up schedule, comorbidity or poor general physical/mental health, or drug or alcohol abuse issues).
  24. Subject fails pre-operative or intraoperative eligibility criteria as specified in section 7.4.2. of the clinical investigation plan.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treated group
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
the implantation site is injected with the AGN1 implant material
No Intervention: Control group
Subject receives standard of care to repair the index hip fracture and no AGN1 LOEP treatment on the target unfractured contralateral hip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of secondary fragility hip fractures
Time Frame: Interim Analysis, approximately 30 Months
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)
Time Frame: Interim Analysis, approximately 30 Months
Comparison of incidence of AEs and SAEs among the Treated Group vs. Control Group.
Interim Analysis, approximately 30 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Areal bone mineral density (aBMD)
Time Frame: 12 months and 24 months
Total hip areal bone mineral density in target hips of the Treated Group compared to the Control Group
12 months and 24 months
Trabecular Bone Score (TBS)
Time Frame: 12 months and 24 months
Continuous densitometry measure of the target hip bone of the Treated Group compared to the Control Group
12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AgNovos Healthcare, LLC

Collaborators

Avania
BioClinica, Inc.
CMIC Co, Ltd. Japan
Emergent Clinical Consulting, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2021

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGN-CIP-100 / AGN-CIP-100-CA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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