Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures

Status: Recruiting
Location: See all (54) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 65
Healthy Volunteers: f
View:

• Subject is a postmenopausal female at least 1-year post menses and at least 65 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

∙ 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

• Subject is expected to be ambulatory after the hip fracture repair procedure.

• Informed consent is provided by the subject or the subject's LAR.

• 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.

Locations
Other Locations
Austria
Innsbruck Hospital
RECRUITING
Innsbruck
Canada
Health Sciences Centre - Eastern Health
RECRUITING
St. John's
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
France
CHU Grenoble-Alpes
RECRUITING
Grenoble
CHU Lyon
RECRUITING
Lyon
CHU Toulouse
RECRUITING
Toulouse
Germany
University Hospital of Duesseldorf
RECRUITING
Düsseldorf
Justus Liebig Universitat Gießen
TERMINATED
Giessen
Medizinische Hochschule Hannover
RECRUITING
Hanover
Universitatsklinikum Schleswig-Holstein
RECRUITING
Kiel
Klinikum der Universität München
RECRUITING
München
University Hospital of Münster
TERMINATED
Münster
Universitätsklinikum Regensburg
RECRUITING
Regensburg
BG Klinik Tuebingen
RECRUITING
Tübingen
Helios Wuppertal
RECRUITING
Wuppertal
Italy
Azienda Ospedaliero Universitaria Careggi
RECRUITING
Florence
ASST Gaetano Pini CTO
RECRUITING
Milan
University Hospital San Raffaele Milano
RECRUITING
Milan
Policlinico Tor Vergata
RECRUITING
Rome
CTO Torino
RECRUITING
Torino
Japan
Akita City Hospital
RECRUITING
Akita
The University of Tokyo Hospital
RECRUITING
Bunkyō-ku
St. Mary's Hospital
RECRUITING
Fukuoka
Iwata City Hospital
RECRUITING
Iwata
Jutendo University Shizuoka Hospital
TERMINATED
Izunokuni
Kanto Rosai Hospital
RECRUITING
Kawasaki
Shin-yurigaoka General Hospital
RECRUITING
Kawasaki-shi
Shin-Yurigaoka General Hospital
RECRUITING
Kawasaki-shi
Chikamori Hospital
RECRUITING
Kochi
Southern Tohoku General Hospital
RECRUITING
Kōriyama
National Hospital Organization Kumamoto Medical Center
RECRUITING
Kumamoto
Kagawa Rosai Hospital
RECRUITING
Marugame
Hyogo Prefectural Nishinomiya Hospital
RECRUITING
Nishinomiya
Okayama Medical Center
RECRUITING
Okayama
Saga-Ken Medical Centre Koseikan
RECRUITING
Saga
Japanese Red Cross Shizuoka Hospital
RECRUITING
Shizuoka
Netherlands
Deventer Hospital
RECRUITING
Deventer
Saint Anna Ziekenhuis
TERMINATED
Geldrop
Maastricht UMC
RECRUITING
Maastricht
Isala Hospital
RECRUITING
Zwolle
Spain
Clinic de Barcelona
RECRUITING
Barcelona
Vall d'Hebron University Hospital
RECRUITING
Barcelona
Hospital Universitario de Basurto
RECRUITING
Bilbao
Galdakao-Usansolo Hospital
RECRUITING
Galdakao
Hospital Neuro-Traumatológico de Jaén
RECRUITING
Jaén
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
PARC Tauli
RECRUITING
Sabadell
Mutua de Terrassa University Hospital
RECRUITING
Terrassa
Valladolid University Clinic Hospital
RECRUITING
Valladolid
United Kingdom
Birmingham Heartlands Hospital
RECRUITING
Birmingham
Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
Leicester Royal Infirmary
RECRUITING
Leicester
Nottingham University Hospitals, Queen's Medical Center
RECRUITING
Nottingham
Contact Information
Primary
Charles Raymond
restore@agnovos.com
240-753-6421
Time Frame
Start Date: 2021-04-24
Estimated Completion Date: 2029-04-01
Participants
Target number of participants: 2400
Treatments
Experimental: Treated group
Subject receives standard of care to repair the index hip fracture and AGN1 LOEP treatment on the target unfractured contralateral hip
No_intervention: Control group
Subject receives standard of care to repair the index hip fracture and no AGN1 LOEP treatment on the target unfractured contralateral hip
Related Therapeutic Areas
Sponsors
Collaborators: CMIC Co, Ltd. Japan, BioClinica, Inc., Avania, Emergent Clinical Consulting, LLC
Leads: AgNovos Healthcare, LLC

This content was sourced from clinicaltrials.gov