Actively Recruiting
Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures
Led by AgNovos Healthcare, LLC · Updated on 2026-05-13
2400
Participants Needed
66
Research Sites
104 weeks
Total Duration
On this page
Sponsors
A
AgNovos Healthcare, LLC
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating AGN1 LOEP, a local osteo-enhancement procedure, to prevent secondary hip fractures in osteoporotic women who have already had an initial hip fracture and surgery. This randomized controlled trial involves postmenopausal women aged 65 to 91 years who experienced a low-energy fragility hip fracture. The study aims to reduce the chance of a second hip fracture by comparing the new treatment to standard care alone. Participants will be randomly assigned to one of two groups: the treated group receives standard hip fracture repair plus the AGN1 LOEP procedure on the opposite unfractured hip, while the control group receives standard repair without the AGN1 LOEP treatment. The AGN1 LOEP procedure involves injecting implant material into the unfractured hip immediately after surgery. This study is single-blinded, except in Canada where it is not blinded. Participants will attend scheduled follow-up visits at 6 weeks, 6 months, and every 6 months thereafter for at least 5 years. During these visits, researchers will monitor for new hip fractures, adverse events, and measure bone mineral density at 12 and 24 months. The study will assess the cumulative incidence of secondary hip fractures and safety outcomes over time, with a minimum follow-up of 5 years after the initial hip repair surgery.
CONDITIONS
Brief Title
RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal female at least 1 year past menses and aged between 65 and 91 years
- Presents with a low-energy hip fracture requiring surgical repair
- Has at least one additional risk factor for secondary hip fracture such as moderate or high fall risk, history of 2 or more falls in past year, vertigo, dizziness, postural hypotension, low hip T-score (< -2.5), taking more than 3 daily prescription medications, visual impairment, prior non-hip fragility fracture, cognitive frailty, Parkinson's disease stage 3 or 4, or 10-year hip fracture risk over 15% by FRAX tool
- Expected to be ambulatory after hip fracture repair
- Provides informed consent or consent by legally authorized representative who understands post-operative requirements
- Willing and able to participate in screening, treatment, and all follow-up visits for the full study duration
You will not qualify if you...
- Currently enrolled in another interventional study affecting the target hip
- History of hip surgery or prior fracture on the unfractured hip opposite the index hip
- Has additional new fractures at admission that may impair mobility or recovery
- Infection or non-intact skin or open wounds near the intended treatment site
- Ongoing unexplained worsening pain in the unfractured hip over past 3 months
- Radiological evidence of major bone or joint disease or atypical femoral fractures
- History of metabolic bone disease other than osteoporosis
- Active cancer
- End stage renal failure (eGFR < 15 mL/min)
- Moderate or severe cognitive impairment (SPMSQ score 5 or higher)
- Known allergy to calcium-based bone fillers
- Considered a poor candidate for elective orthopedic surgery due to mental health or substance abuse
- Fails pre-operative or intraoperative eligibility criteria as per study plan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo surgical repair of the index hip fracture. Those randomized to the treated group receive the AGN1 LOEP device implantation on the unfractured contralateral hip immediately following surgery.
1 surgical visit (in-person)
Duration - Minimum of 5 years
Participants attend scheduled follow-up visits to monitor recovery and assess outcomes including bone mineral density and fracture incidence.
Visits at 6 weeks, 6 months, and every 6 months thereafter
Trial Site Locations
Total: 66 locations
1
Innsbruck Hospital
Innsbruck, Austria
Actively Recruiting
2
Ziekenhuis Oost-Limburg
Genk, Belgium
Actively Recruiting
3
Ghent University Hospital
Ghent, Belgium
Actively Recruiting
4
UZ Leuven
Leuven, Belgium
Actively Recruiting
5
Vitaz Sint-Niklaas
Sint-Niklaas, Belgium
Actively Recruiting
6
Health Sciences Centre - Eastern Health
St. John's, Newfoundland and Labrador, Canada
Withdrawn
7
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Actively Recruiting
8
Sunnybrook Health Sciences Centre
North York, Ontario, Canada
Actively Recruiting
9
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
10
CHU de Nice
Nice, Provence-Alpes-Côte d'Azur Region, France
Actively Recruiting
11
CHU Amiens
Amiens, France
Actively Recruiting
12
CHU Grenoble-Alpes
Grenoble, France
Actively Recruiting
13
CHU Lyon
Lyon, France
Withdrawn
14
CHU Toulouse
Toulouse, France
Withdrawn
15
Charite University Hosptial
Berlin, Germany
Actively Recruiting
16
University Hospital of Duesseldorf
Düsseldorf, Germany
Active, Not Recruiting
17
Justus Liebig Universitat Gießen
Giessen, Germany
Withdrawn
18
Medizinische Hochschule Hannover
Hanover, Germany
Active, Not Recruiting
19
Universitatsklinikum Schleswig-Holstein
Kiel, Germany
Actively Recruiting
20
Klinikum der Universität München
München, Germany
Actively Recruiting
21
University Hospital of Münster
Münster, Germany
Withdrawn
22
Universitätsklinikum Regensburg
Regensburg, Germany
Withdrawn
23
BG Klinik Tuebingen
Tübingen, Germany
Active, Not Recruiting
24
Helios Wuppertal
Wuppertal, Germany
Active, Not Recruiting
25
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Actively Recruiting
26
ASST Gaetano Pini CTO
Milan, Italy
Actively Recruiting
27
University Hospital San Raffaele Milano
Milan, Italy
Withdrawn
28
Policlinico Tor Vergata
Rome, Italy
Actively Recruiting
29
CTO Torino
Torino, Italy
Actively Recruiting
30
Akita City Hospital
Akita, Akita, Japan
Actively Recruiting
31
Southern Tohoku General Hospital
Kōriyama, Fukushima, Japan
Actively Recruiting
32
Hyogo Prefectural Nishinomiya Hospital
Nishinomiya, Hyōgo, Japan
Actively Recruiting
33
Kagawa Rosai Hospital
Marugame, Kagawa-ken, Japan
Actively Recruiting
34
Kanto Rosai Hospital
Kawasaki, Kanagawa, Japan
Actively Recruiting
35
Chikamori Hospital
Kochi, Kochi, Japan
Active, Not Recruiting
36
Okayama Medical Center
Okayama, Okayama-ken, Japan
Actively Recruiting
37
Jutendo University Shizuoka Hospital
Izunokuni, Shizuoka, Japan
Withdrawn
38
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
Withdrawn
39
St. Mary's Hospital
Fukuoka, Japan
Actively Recruiting
40
Iwata City Hospital
Iwata, Japan
Actively Recruiting
41
Shin-Yurigaoka General Hospital
Kawasaki-shi, Japan
Actively Recruiting
42
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan
Actively Recruiting
43
Saga-Ken Medical Centre Koseikan
Saga, Japan
Actively Recruiting
44
Japanese Red Cross Shizuoka Hospital
Shizuoka, Japan
Actively Recruiting
45
Deventer Hospital
Deventer, Netherlands
Actively Recruiting
46
Saint Anna Ziekenhuis
Geldrop, Netherlands
Withdrawn
47
Maastricht UMC
Maastricht, Netherlands
Actively Recruiting
48
Isala Hospital
Zwolle, Netherlands
Active, Not Recruiting
49
Vall d'Hebron University Hospital
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
50
Valladolid University Clinic Hospital
Valladolid, Valladolid, Spain, 47003
Actively Recruiting
51
Clinic de Barcelona
Barcelona, Spain
Actively Recruiting
52
Hospital Universitario de Basurto
Bilbao, Spain
Actively Recruiting
53
Galdakao-Usansolo Hospital
Galdakao, Spain
Actively Recruiting
54
Hospital Neuro-Traumatológico de Jaén
Jaén, Spain
Actively Recruiting
55
Hospital Clínico San Carlos
Madrid, Spain
Actively Recruiting
56
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
57
Hospital Universitario Infanta Leonor
Madrid, Spain
Actively Recruiting
58
Hospital St Joan de Deu
Manresa, Spain
Actively Recruiting
59
PARC Tauli
Sabadell, Spain
Active, Not Recruiting
60
Mutua de Terrassa University Hospital
Terrassa, Spain
Actively Recruiting
61
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Withdrawn
62
Leicester Royal Infirmary
Leicester, England, United Kingdom
Actively Recruiting
63
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom
Actively Recruiting
64
Queen Elizabeth Glasgow
Glasgow, United Kingdom
Actively Recruiting
65
Wythenshawe Hospital Manchester
Manchester, United Kingdom
Actively Recruiting
66
Nottingham University Hospitals, Queen's Medical Center
Nottingham, United Kingdom
Actively Recruiting
Research Team
C
Charles Raymond
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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