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)
Cumulative incidence of secondary fragility hip fractures — 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) — Interim Analysis, approximately 30 Months Comparison of incidence of AEs and SAEs among the Treated Group vs. Control Group.
Trial sites (66)
Facility
City
Region
Status
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.
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.
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