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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04796350
Other study ID # AGN-CIP-100 / AGN-CIP-100-CA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 24, 2021
Est. completion date April 1, 2029

Study information

Verified date March 2024
Source AgNovos Healthcare, LLC
Contact Adam Lowe
Phone +1-240-676-2200
Email restore@agnovos.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.


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: 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2400
Est. completion date April 1, 2029
Est. primary completion date April 1, 2027
Accepts healthy volunteers No
Gender Female
Age group 65 Years and older
Eligibility 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 that, in the opinion of the investigator, would further compromise patient mobility, rehabilitation, and/or recovery or subject has three or more new fractures in addition to the index hip fracture. 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 a diagnosed and ongoing calcium metabolism disorder. 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.

Study Design


Intervention

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

Locations

Country Name City State
Austria Innsbruck Hospital Innsbruck
Denmark Aarhus University Hospital Aarhus
France CHU Grenoble-Alpes Grenoble
France CHU Lyon Lyon
France CHU Toulouse Toulouse
Germany University Hospital of Duesseldorf Düsseldorf
Germany Justus Liebig Universitat Gießen Gießen
Germany Medizinische Hochschule Hannover Hannover
Germany Universitatsklinikum Schleswig-Holstein Kiel
Germany Klinikum der Universität München München
Germany University Hospital of Münster Münster
Germany Universitätsklinikum Regensburg Regensburg
Germany BG Klinik Tuebingen Tuebingen
Italy Azienda Ospedaliero Universitaria Careggi Firenze
Italy ASST Gaetano Pini CTO Milano
Italy University Hospital San Raffaele Milano Milano
Italy Policlinico Tor Vergata Rome
Japan Akita City Hospital Akita-shi Akita
Japan The University of Tokyo Hospital Bunkyo-Ku Tokyo
Japan St. Mary's Hospital Fukuoka
Japan Iwata City Hospital Iwata
Japan Jutendo University Shizuoka Hospital Izunokuni City Shizuoka
Japan Kanto Rosai Hospital Kawasaki City Kanagawa
Japan Shin-yurigaoka General Hospital Kawasaki-Shi Kanagawa
Japan Shin-Yurigaoka General Hospital Kawasaki-shi
Japan Southern Tohoku General Hospital Koriyama Fukushima
Japan Chikamori Hospital Kouchi City Kochi
Japan National Hospital Organization Kumamoto Medical Center Kumamoto
Japan Kagawa Rosai Hospital Marugame Kagawa
Japan Hyogo Prefectural Nishinomiya Hospital Nishinomiya Hyogo
Japan Okayama Medical Center Okayama City Okayama
Japan Saga-Ken Medical Centre Koseikan Saga
Japan Japanese Red Cross Shizuoka Hospital Shizuoka
Netherlands Deventer Hospital Deventer
Netherlands Saint Anna Ziekenhuis Geldrop
Netherlands Maastricht UMC Maastricht
Netherlands Isala Hospital Zwolle
Spain Clinic de Barcelona Barcelona
Spain Vall d'Hebron University Hospital Barcelona
Spain Hospital Universitario de Basurto Bilbao
Spain Galdakao-Usansolo Hospital Galdakao
Spain Hospital Neuro-Traumatológico de Jaén Jaén
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain PARC Tauli Sabadell
Spain Mutua de Terrassa University Hospital Terrassa
Spain Valladolid University Clinic Hospital Valladolid
United Kingdom Birmingham Heartlands Hospital Birmingham England
United Kingdom Royal Infirmary of Edinburgh Edinburgh Scotland
United Kingdom Leicester Royal Infirmary Leicester England
United Kingdom Nottingham University Hospitals, Queen's Medical Center Nottingham

Sponsors (5)

Lead Sponsor Collaborator
AgNovos Healthcare, LLC Avania, BioClinica, Inc., CMIC Co, Ltd. Japan, Emergent Clinical Consulting, LLC

Countries where clinical trial is conducted

Austria,  Denmark,  France,  Germany,  Italy,  Japan,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Interim Analysis, approximately 30 Months
Primary 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. Interim Analysis, approximately 30 Months
Secondary Areal bone mineral density (aBMD) Total hip areal bone mineral density in target hips of the Treated Group compared to the Control Group 12 months and 24 months
Secondary Trabecular Bone Score (TBS) Continuous densitometry measure of the target hip bone of the Treated Group compared to the Control Group 12 months and 24 months
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