Testing AGN1 LOEP treatment for fragility fracture
Official title: RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures
- 2 groups
- Sites in St. John's and Halifax
- Recruiting
Interventions
- Medical device
AGN1 LOEP treatment
the implantation site is injected with the AGN1 implant material
Canadian Sites (3)
2 of 3 recruiting
- Recruiting
QEII Health Sciences Centre
Halifax, Nova Scotia
- Recruiting
Sunnybrook Health Sciences Centre
North York, Ontario
- Withdrawn
Health Sciences Centre - Eastern Health
St. John's, Newfoundland and Labrador
Eligibility Criteria
See who this study is looking for43 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- +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
- +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 siteTrial siteA hospital or clinic where a study is actually run.Read more → 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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, treatment, and all follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → evaluations for the full duration of the study has been documented.
Exclusion
- −Subject has known allergies to calcium-based bone void fillers.
- −Criterion omitted
- −Criterion omitted
- −Subject is currently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in another interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical study affecting the target hip.
- −Subject has new fractures in addition to the index hip fracture at admission that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would further compromise patient mobility, rehabilitation, or recovery.
- −Subject has an infection at the LOEP intended treatment siteTrial siteA hospital or clinic where a study is actually run.Read more → 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.
- −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.
- −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 criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more → as specified in section 7.4.2. of the clinical investigation plan.
- −Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives AGN1 LOEP treatment.
Registry label: A: Treated group
Group B receives no study treatment and is followed for comparison.
Registry label: B: Control group
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 65 years to 91 years.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,400 people.
The study is currently expected to finish around April 2029.
The main measurement is taken over: Interim Analysis, approximately 30 Months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Cumulative incidence of secondary fragility hip fractures — measured over Interim Analysis, approximately 30 Months.
Cumulative Incidence of Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) and Serious Adverse EventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → (SAEs) — measured over Interim Analysis, approximately 30 Months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04796350 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About AGN1 LOEP treatmentDevice
the implantation site is injected with the AGN1 implant material
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 65 years to 91 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 65 years to 91 years.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Interim Analysis, approximately 30 Months.
The study as a whole is currently expected to finish around 2029-04-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,400 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: St. John's, Newfoundland and Labrador, Canada; Halifax, Nova Scotia, Canada; North York, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.