Fragility FractureNCT04796350
RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
A study testing AGN1 LOEP treatment in people with Fragility Fracture and Hip Fractures, run by AgNovos Healthcare, LLC at 66 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 91 years, women only
- Conditions the study is for
- Fragility Fracture, Hip Fractures, Osteoporosis
- What is being tested?
- AGN1 LOEP treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 66 sitesin 11 countries
- Study dates
- 24 Apr 2021to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 91 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age and less than 92 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
Show all 20Show fewer
- 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 cognitive impairment determined by SPMSQ ≤ to 4) 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. "Ambulatory" is defined as a patient's ability to ambulate beyond simple transfers with or without assistive devices.
- Informed consent is provided by the subject or the subject's LAR. Use of an LAR to obtain patient consent requires that the patient must understand and be able to participate in post operative restrictions and requirements.
- 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.
Who cannot join
- Criterion omitted
- Criterion omitted
- Subject is currently enrolled in another interventional clinical study affecting the target hip.
- Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture.
- Subject has new fractures in addition to the index hip fracture at admission that, in the opinion of the investigator, would further compromise patient mobility, rehabilitation, or recovery.
- 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.
Show all 24Show fewer
- 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.
- Criterion omitted
- Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
- Criterion omitted
- Subject has active cancer
- Criterion omitted
- Criterion omitted
- Criterion omitted
- Criterion omitted
- Criterion omitted
- Subject has end stage renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 15 mL/min.
- Criterion omitted
- Criterion omitted
- Subject has moderate or severe cognitive impairment as assessed by an SPMSQ of 5 or higher.
- 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., poor mental health, or active drug or alcohol abuse issues), and or subject would not be a good candidate to undergo an ELECTIVE orthopedic surgical procedure such as a total hip arthroplasty in her current medical, physiological condition.
- Subject fails pre-operative or intraoperative eligibility criteria as specified in section 7.4.2. of the clinical investigation plan.
Trial locations and contacts
66 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
66 sites in 11 countries
Japan15 sites, 12 recruiting
- Recruiting
Akita City Hospital
Akita, Akita
RESTORE Study, restore@agnovos.com
- Withdrawn
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo
- Recruiting
St. Mary's Hospital
Fukuoka
RESTORE Study, restore@agnovos.com
- Recruiting
Iwata City Hospital
Iwata
RESTORE Study, restore@agnovos.com
- Withdrawn
Jutendo University Shizuoka Hospital
Izunokuni, Shizuoka
- Recruiting
Kanto Rosai Hospital
Kawasaki, Kanagawa
RESTORE Study, restore@agnovos.com
- Recruiting
Shin-Yurigaoka General Hospital
Kawasaki-shi
RESTORE Study, restore@agnovos.com
- Active, not recruiting
Chikamori Hospital
Kochi, Kochi
- Recruiting
Southern Tohoku General Hospital
Kōriyama, Fukushima
RESTORE Study, restore@agnovos.com
- Recruiting
National Hospital Organization Kumamoto Medical Center
Kumamoto
RESTORE Study, restore@agnovos.com
- Recruiting
Kagawa Rosai Hospital
Marugame, Kagawa-ken
RESTORE Study, restore@agnovos.com
- Recruiting
Hyogo Prefectural Nishinomiya Hospital
Nishinomiya, Hyōgo
RESTORE Study, restore@agnovos.com
- Recruiting
Okayama Medical Center
Okayama, Okayama-ken
RESTORE Study, restore@agnovos.com
- Recruiting
Saga-Ken Medical Centre Koseikan
Saga
RESTORE Study, restore@agnovos.com
- Recruiting
Japanese Red Cross Shizuoka Hospital
Shizuoka
RESTORE Study, restore@agnovos.com
Spain12 sites, 11 recruiting
- Recruiting
Vall d'Hebron University Hospital
Barcelona, Barcelona, 08035
RESTORE Study, restore@agnovos.com
- Recruiting
Clinic de Barcelona
Barcelona
RESTORE Study, restore@agnovos.com
- Recruiting
Hospital Universitario de Basurto
Bilbao
RESTORE Study, restore@agnovos.com
- Recruiting
Galdakao-Usansolo Hospital
Galdakao
RESTORE Study, restore@agnovos.com
- Recruiting
Hospital Neuro-Traumatológico de Jaén
Jaén
RESTORE Study, restore@agnovos.com
- Recruiting
Hospital Clínico San Carlos
Madrid
RESTORE Study, restore@agnovos.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid
RESTORE Study, restore@agnovos.com
- Recruiting
Hospital Universitario Infanta Leonor
Madrid
Ricardo Larrainzar, +34911918000, ricardo.larrainzar@salud.madrid.org
- Recruiting
Hospital St Joan de Deu
Manresa
Maria Rosinés, +938 75 93 00, drosines@althaia.cat
- Active, not recruiting
PARC Tauli
Sabadell
- Recruiting
Mutua de Terrassa University Hospital
Terrassa
RESTORE Study, restore@agnovos.com
- Recruiting
Valladolid University Clinic Hospital
Valladolid, Valladolid, 47003
RESTORE Study, restore@agnovos.com
Germany10 sites, 3 recruiting
- Recruiting
Charite University Hosptial
Berlin
Anne Zergiebel, +493045050, anne.zergiebel@charite.de
- Active, not recruiting
University Hospital of Duesseldorf
Düsseldorf
- Withdrawn
Justus Liebig Universitat Gießen
Giessen
- Active, not recruiting
Medizinische Hochschule Hannover
Hanover
- Recruiting
Universitatsklinikum Schleswig-Holstein
Kiel
RESTORE Study, restore@agnovos.com
- Recruiting
Klinikum der Universität München
München
RESTORE Study, restore@agnovos.com
- Withdrawn
University Hospital of Münster
Münster
- Withdrawn
Universitätsklinikum Regensburg
Regensburg
- Active, not recruiting
BG Klinik Tuebingen
Tübingen
- Active, not recruiting
Helios Wuppertal
Wuppertal
United Kingdom6 sites, 5 recruiting
- Withdrawn
Birmingham Heartlands Hospital
Birmingham, England
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh, Scotland
RESTORE Study, restore@agnovos.com
- Recruiting
Queen Elizabeth Glasgow
Glasgow
David Shields, +441412011100, david.shields@nhs.scot
- Recruiting
Leicester Royal Infirmary
Leicester, England
RESTORE Study, restore@agnovos.com
- Recruiting
Wythenshawe Hospital Manchester
Manchester
Ronny Davies, +441619987070, ronnie.davies@mft.nhs.uk
- Recruiting
Nottingham University Hospitals, Queen's Medical Center
Nottingham
RESTORE Study, restore@agnovos.com
France5 sites, 3 recruiting
- Recruiting
CHU Amiens
Amiens
Sandrine Soriot- Thomas, +33322088000, sandrine@chuamiens.fr
- Recruiting
CHU Grenoble-Alpes
Grenoble
RESTORE Study, restore@agnovos.com
- Withdrawn
CHU Lyon
Lyon
- Recruiting
CHU de Nice
Nice, Provence-Alpes-Côte d'Azur Region
Anne Fregéac, +33 4 92 03 77 77, fregeac.a@chu-nice.fr
- Withdrawn
CHU Toulouse
Toulouse
Italy5 sites, 4 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Careggi
Florence
RESTORE Study, restore@agnovos.com
- Recruiting
ASST Gaetano Pini CTO
Milan
RESTORE Study, restore@agnovos.com
- Withdrawn
University Hospital San Raffaele Milano
Milan
- Recruiting
Policlinico Tor Vergata
Rome
RESTORE Study, restore@agnovos.com
- Recruiting
CTO Torino
Torino
RESTORE Study, restore@agnovos.com
Belgium4 sites, 4 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk
Richard Witvrouw, +3289325050, richard.witvrouw@zol.be
- Recruiting
Ghent University Hospital
Ghent
Jan Van Meirhaeghe, +3293322111, jan.vanmeirhaeghe@uzgent.be
- Recruiting
UZ Leuven
Leuven
Willem-Jan Metsemakers, +32 16 34 46 66, willem-jan.metsemakers@uzleuven.be
- Recruiting
Vitaz Sint-Niklaas
Sint-Niklaas
Jo De Schepper, +3237606060, jodeschepper@live.com
Netherlands4 sites, 2 recruiting
- Recruiting
Deventer Hospital
Deventer
RESTORE Study, restore@agnovos.com
- Withdrawn
Saint Anna Ziekenhuis
Geldrop
- Recruiting
Maastricht UMC
Maastricht
RESTORE Study, restore@agnovos.com
- Active, not recruiting
Isala Hospital
Zwolle
Canada3 sites, 2 recruiting
- Recruiting
QEII Health Sciences Centre
Halifax, Nova Scotia
Curtis Giacomantonio, +1 902-473-2700, curtis.giacomantonio@nshealth.ca
- Recruiting
Sunnybrook Health Sciences Centre
North York, Ontario
Meghan Ryan, +1 416-480-6100, meghan.ryan@sri.utoronto.ca
- Withdrawn
Health Sciences Centre - Eastern Health
St. John's, Newfoundland and Labrador
Austria1 site, 1 recruiting
- Recruiting
Innsbruck Hospital
Innsbruck
RESTORE Study, restore@agnovos.com
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
RESTORE Study, restore@agnovos.com
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Fragility Fracture, Hip Fractures, Osteoporosis
- Being tested
- AGN1 LOEP treatment
- Keywords
- Osteoporosis, Hip Fracture, Fragility Fracture, LOEP, RESTORE, Local osteo-enhancement procedure
- Medical subject headings
- Hip Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN1 LOEP treatmentDevice
the implantation site is injected with the AGN1 implant material
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Experimental | Subject receives standard of care to repair the index hip fracture and AGN1 LOEP treatment on the target unfractured contralateral hip Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Interim Analysis, approximately 30 Months
Secondary outcomes (1)
Areal bone mineral density (aBMD)
Total hip areal bone mineral density in target hips of the Treated Group compared to the Control Group
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start24 Apr 2021
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fragility FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AgNovos Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania, CMIC Co, Ltd. Japan, BioClinica, Inc., Emergent Clinical Consulting, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796350
- Sponsor's protocol ID
- AGN-CIP-100 / AGN-CIP-100-CA
- Status last verified
- May 2026
- First submitted
- 8 Mar 2021
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The sponsor is limited in its flexibility to share data given informed consent forms. Requests for data sharing will be considered by the study sponsor on a case-by-case basis
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04796350
- Acronym / sponsor ID
- AGN-CIP-100 / AGN-CIP-100-CA
- Conditions
- Fragility Fracture, Hip Fractures, Osteoporosis
- Keywords
- Osteoporosis, Hip Fracture, Fragility Fracture, LOEP, RESTORE, Local osteo-enhancement procedure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- AgNovos Healthcare, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Avania, CMIC Co, Ltd. Japan, BioClinica, Inc., Emergent Clinical Consulting, LLC
- Study start
- 24 Apr 2021 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group | Experimental | Device: AGN1 LOEP treatmentSubject receives standard of care to repair the index hip fracture and AGN1 LOEP treatment on the target unfractured contralateral hip |
| 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 |
Who may qualify
- Ages
- 65 to 91 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (20 listed)
- Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age and less than 92 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):
- Subject is expected to be ambulatory after the hip fracture repair procedure. "Ambulatory" is defined as a patient's ability to ambulate beyond simple transfers with or without assistive devices.
- Informed consent is provided by the subject or the subject's LAR. Use of an LAR to obtain patient consent requires that the patient must understand and be able to participate in post operative restrictions and requirements.
Key exclusion criteria (24 listed)
- Criterion omitted
- Criterion omitted
- Subject is currently enrolled in another interventional clinical study affecting the target hip.
- Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture.
- Subject has new fractures in addition to the index hip fracture at admission that, in the opinion of the investigator, would further compromise patient mobility, rehabilitation, or recovery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGN1 LOEP treatmentthe implantation site is injected with the AGN1 implant material | Device | Treated group |
Primary outcome
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.
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.
1 secondary outcome
Areal bone mineral density (aBMD)
Time frame: 12 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Japan Registry of Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The sponsor is limited in its flexibility to share data given informed consent forms. Requests for data sharing will be considered by the study sponsor on a case-by-case basis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
66 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AGN1 LOEP treatment in people with Fragility Fracture and Hip Fractures, run by AgNovos Healthcare, LLC at 66 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Japan, Spain, Germany, United Kingdom, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Raymond (240-753-6421, restore@agnovos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of secondary fragility hip fractures (time frame: Interim Analysis, approximately 30 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.