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RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

Sponsor: AgNovos Healthcare, LLC

NCT ID: NCT04796350

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AGN1 LOEP treatment (device)
How long the study runs
Study runs about 96 months (dates as stated)
About the drug or intervention
AGN1 LOEP treatment — device: the implantation site is injected with the AGN1 implant material
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
65 Years to 91 Years
Who
Female
Number of participants
2,400
Started
2021-04-24
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for fragility fracture
  • • NA - 2,400 participants
  • • A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures

Who can take part?

  • • Ages 65 Years to 91 Years
  • • Diagnosed with fragility fracture
  • • Female only

Where?

  • • Birmingham - Birmingham Heartlands Hospital
  • • Leicester - Leicester Royal Infirmary
  • • Edinburgh - Royal Infirmary of Edinburgh
  • • Glasgow - Queen Elizabeth Glasgow
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

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.

Fragility FractureHip FracturesOsteoporosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 65 Years - 91 Years
  • Who can join: Female only

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age and less than 92 years...
  • ✓Subject presents with a low-energy index fragility hip fracture in one hip and will undergo surgical repair of the...
  • ✓Subject has at least one of the following additional risk factors for a secondary hip fracture (as determined by...
  • ✓Documented falls assessment indicating subject is at moderate or high risk of falls
  • ✓Falls history (2 or more falls in the previous 12 months)

Who cannot take part

  • ✗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...
  • ✗Subject has new fractures in addition to the index hip fracture at admission that, in the opinion of the...
  • ✗Subject has an infection at the LOEP intended treatment site or has non-intact skin or acute traumatic injuries with...
See the full criteria
Inclusion Criteria: 1. 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. 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 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 4. 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. 5. 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. 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. Criterion omitted 2. Criterion omitted 3. Subject is currently enrolled in another interventional clinical study affecting the target hip. 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 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. 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. Criterion omitted 10. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia). 11. Criterion omitted 12. Subject has active cancer 13. Criterion omitted 14. Criterion omitted 15. Criterion omitted 16. Criterion omitted 17. Criterion omitted 18. Subject has end stage renal insufficiency defined as an estimated glomerular filtration rate (eGFR) \< 15 mL/min. 19. Criterion omitted 20. Criterion omitted 21. Subject has moderate or severe cognitive impairment as assessed by an SPMSQ of 5 or higher. 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., 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. 24. Subject fails pre-operative or intraoperative eligibility criteria as specified in section 7.4.2. of the clinical investigation plan.

Where Is This Study? (6 UK sites)

Birmingham Heartlands Hospital

Birmingham, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Leicester Royal Infirmary

Leicester, United Kingdom

Recruiting
Site contact (verified)
RESTORE Studyrestore@agnovos.com

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Recruiting
Site contact (verified)
RESTORE Studyrestore@agnovos.com

Queen Elizabeth Glasgow

Glasgow, United Kingdom

Recruiting
Site contact (verified)

Wythenshawe Hospital Manchester

Manchester, United Kingdom

Recruiting
Site contact (verified)

Nottingham University Hospitals, Queen's Medical Center

Nottingham, United Kingdom

Recruiting
Site contact (verified)
RESTORE Studyrestore@agnovos.com

How to Get in Touch

Charles Raymond

Sponsor contact

CONTACT

240-753-6421 restore@agnovos.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05