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RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

Primary Purpose

Fragility Fracture, Hip Fractures, Osteoporosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AGN1 LOEP treatment
Sponsored by
AgNovos Healthcare, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fragility Fracture focused on measuring Osteoporosis, Hip Fracture, Fragility Fracture

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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.
  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 albumin corrected serum calcium levels outside the normal laboratory range or has a pre-existing calcium metabolism disorder (e.g. hypercalcemia).
  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.

Sites / Locations

  • Innsbruck HospitalRecruiting
  • University Hospital of Duesseldorf
  • Justus Liebig Universitat GießenRecruiting
  • Medizinische Hochschule HannoverRecruiting
  • Universitatsklinikum Schleswig-HolsteinRecruiting
  • Klinikum der Universität München
  • University Hospital of MünsterRecruiting
  • Akita City HospitalRecruiting
  • Southern Tohoku General HospitalRecruiting
  • Hyogo Prefectural Nishinomiya HospitalRecruiting
  • Kagawa Rosai HospitalRecruiting
  • Kanto Rosai HospitalRecruiting
  • Shin-yurigaoka General HospitalRecruiting
  • Chikamori HospitalRecruiting
  • Okayama Medical CenterRecruiting
  • Jutendo University Shizuoka HospitalRecruiting
  • The University of Tokyo HospitalRecruiting
  • Deventer HospitalRecruiting
  • Isala HospitalRecruiting
  • Vall d'Hebron University HospitalRecruiting
  • Clinic de BarcelonaRecruiting
  • PARC TauliRecruiting
  • Mutua de Terrassa University HospitalRecruiting
  • Valladolid University Clinic HospitalRecruiting
  • Nottingham University Hospitals, Queen's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treated group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Areal bone mineral density (aBMD)
Total hip areal bone mineral density in target hips of the Treated Group compared to the Control Group
Trabecular Bone Score (TBS)
Continuous densitometry measure of the target hip bone of the Treated Group compared to the Control Group

Full Information

First Posted
March 8, 2021
Last Updated
November 28, 2022
Sponsor
AgNovos Healthcare, LLC
Collaborators
Avania, CMIC Co, Ltd. Japan, Baim Institute for Clinical Research, BioClinica, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04796350
Brief Title
RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
Official Title
Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2021 (Actual)
Primary Completion Date
April 1, 2027 (Anticipated)
Study Completion Date
April 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AgNovos Healthcare, LLC
Collaborators
Avania, CMIC Co, Ltd. Japan, Baim Institute for Clinical Research, BioClinica, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is an event driven, randomized, controlled, prospective, single blinded, 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: Treated Group - receives standard of care to repair the index hip fracture and AGN1 LOEP treatment on the target unfractured contralateral hip 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fragility Fracture, Hip Fractures, Osteoporosis
Keywords
Osteoporosis, Hip Fracture, Fragility Fracture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treated group
Arm Type
Experimental
Arm Description
Subject receives standard of care to repair the index hip fracture and AGN1 LOEP treatment on the target unfractured contralateral hip
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Subject receives standard of care to repair the index hip fracture and no AGN1 LOEP treatment on the target unfractured contralateral hip
Intervention Type
Device
Intervention Name(s)
AGN1 LOEP treatment
Intervention Description
the implantation site is injected with the AGN1 implant material
Primary Outcome Measure Information:
Title
Cumulative incidence of secondary fragility hip fractures
Description
Comparison of incidence of secondary fragility hip fractures in the target hip among the Treated Group vs. Control Group.
Time Frame
Interim Analysis, approximately 30 Months
Title
Cumulative Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Comparison of incidence of AEs and SAEs among the Treated Group vs. Control Group.
Time Frame
Interim Analysis, approximately 30 Months
Secondary Outcome Measure Information:
Title
Areal bone mineral density (aBMD)
Description
Total hip areal bone mineral density in target hips of the Treated Group compared to the Control Group
Time Frame
12 months and 24 months
Title
Trabecular Bone Score (TBS)
Description
Continuous densitometry measure of the target hip bone of the Treated Group compared to the Control Group
Time Frame
12 months and 24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Subject is expected to be ambulatory after the hip fracture repair procedure. Informed consent is provided by the subject or the subject's LAR. 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: 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. 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. Subject has uncontrolled diabetes mellitus. Subject has Hb ≤ 9 g/dL at admission. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) ≤ 30 mL/min. Subject has albumin corrected serum calcium levels outside the normal laboratory range or has a pre-existing calcium metabolism disorder (e.g. hypercalcemia). Subject has a Parker Mobility Score ≤ 5. Subject has severe cognitive impairment as assessed by SPMSQ. Subject has known allergies to calcium-based bone void fillers. 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). Subject fails pre-operative or intraoperative eligibility criteria as specified in section 7.4.2. of the clinical investigation plan.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Lowe
Phone
+1-240-676-2200
Email
restore@agnovos.com
Facility Information:
Facility Name
Innsbruck Hospital
City
Innsbruck
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
University Hospital of Duesseldorf
City
Düsseldorf
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Justus Liebig Universitat Gießen
City
Gießen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Kiel
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Klinikum der Universität München
City
München
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
University Hospital of Münster
City
Münster
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Akita City Hospital
City
Akita-shi
State/Province
Akita
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Southern Tohoku General Hospital
City
Kōriyama
State/Province
Fukushima
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Hyogo Prefectural Nishinomiya Hospital
City
Nishinomiya
State/Province
Hyogo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Kagawa Rosai Hospital
City
Marugame
State/Province
Kagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Kanto Rosai Hospital
City
Kawasaki City
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Shin-yurigaoka General Hospital
City
Kawasaki-Shi
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Chikamori Hospital
City
Kouchi City
State/Province
Kochi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Okayama Medical Center
City
Okayama City
State/Province
Okayama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Jutendo University Shizuoka Hospital
City
Izunokuni City
State/Province
Shizuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
The University of Tokyo Hospital
City
Bunkyō-Ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Deventer Hospital
City
Deventer
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Isala Hospital
City
Zwolle
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Clinic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
PARC Tauli
City
Sabadell
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Mutua de Terrassa University Hospital
City
Terrassa
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Valladolid University Clinic Hospital
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com
Facility Name
Nottingham University Hospitals, Queen's Medical Center
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESTORE Study
Email
restore@agnovos.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://jrct.niph.go.jp/en-latest-detail/jRCT2022210008
Description
Japan Registry of Clinical Trials

Learn more about this trial

RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

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