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Clinical Trials in the UK / NCT04796350
Recruiting Not applicable

RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

NCT04796350 · tracked via the Priya Life Science UK tracker
Sponsor
AgNovos Healthcare, LLC
Phase
Not applicable
Started
2021-04-24
Last updated
2026-05-13

Condition(s) studied

Fragility FractureHip FracturesOsteoporosis

Investigational drug(s) / intervention(s)

AGN1 LOEP treatment

AGN1 LOEP treatment: the implantation site is injected with the AGN1 implant material

Study 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.

Eligibility

Sex
FEMALE
Min age
65 Years
Max age
91 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (66)

FacilityCityRegionStatus
Innsbruck Hospital Innsbruck Austria Recruiting
Ziekenhuis Oost-Limburg Genk Belgium Recruiting
Ghent University Hospital Ghent Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
Vitaz Sint-Niklaas Sint-Niklaas Belgium Recruiting
Health Sciences Centre - Eastern Health St. John's Newfoundland and Labrador Withdrawn
QEII Health Sciences Centre Halifax Nova Scotia Recruiting
Sunnybrook Health Sciences Centre North York Ontario Recruiting
Aarhus University Hospital Aarhus Denmark Recruiting
CHU de Nice Nice Provence-Alpes-Côte d'Azur Region Recruiting
CHU Amiens Amiens France Recruiting
CHU Grenoble-Alpes Grenoble France Recruiting
CHU Lyon Lyon France Withdrawn
CHU Toulouse Toulouse France Withdrawn
Charite University Hosptial Berlin Germany Recruiting
University Hospital of Duesseldorf Düsseldorf Germany Active Not Recruiting
Justus Liebig Universitat Gießen Giessen Germany Withdrawn
Medizinische Hochschule Hannover Hanover Germany Active Not Recruiting
Universitatsklinikum Schleswig-Holstein Kiel Germany Recruiting
Klinikum der Universität München München Germany Recruiting
University Hospital of Münster Münster Germany Withdrawn
Universitätsklinikum Regensburg Regensburg Germany Withdrawn
BG Klinik Tuebingen Tübingen Germany Active Not Recruiting
Helios Wuppertal Wuppertal Germany Active Not Recruiting
Azienda Ospedaliero Universitaria Careggi Florence Italy Recruiting
ASST Gaetano Pini CTO Milan Italy Recruiting
University Hospital San Raffaele Milano Milan Italy Withdrawn
Policlinico Tor Vergata Rome Italy Recruiting
CTO Torino Torino Italy Recruiting
Akita City Hospital Akita Akita Recruiting
Southern Tohoku General Hospital Kōriyama Fukushima Recruiting
Hyogo Prefectural Nishinomiya Hospital Nishinomiya Hyōgo Recruiting
Kagawa Rosai Hospital Marugame Kagawa-ken Recruiting
Kanto Rosai Hospital Kawasaki Kanagawa Recruiting
Chikamori Hospital Kochi Kochi Active Not Recruiting
Okayama Medical Center Okayama Okayama-ken Recruiting
Jutendo University Shizuoka Hospital Izunokuni Shizuoka Withdrawn
The University of Tokyo Hospital Bunkyō-Ku Tokyo Withdrawn
St. Mary's Hospital Fukuoka Japan Recruiting
Iwata City Hospital Iwata Japan Recruiting

+ 26 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04796350 on ClinicalTrials.gov ↗ ← All trials in the UK