At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AGN1 LOEP treatment (device)
- How long the study runs
- Study runs about 96 months (dates as stated)
- About the drug or intervention
- AGN1 LOEP treatment — device: the implantation site is injected with the AGN1 implant material
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 65 Years to 91 Years
- Who
- Female
- Number of participants
- 2,400
- Started
- 2021-04-24
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for fragility fracture
- • NA - 2,400 participants
- • A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures
Who can take part?
- • Ages 65 Years to 91 Years
- • Diagnosed with fragility fracture
- • Female only
Where?
- • Birmingham - Birmingham Heartlands Hospital
- • Leicester - Leicester Royal Infirmary
- • Edinburgh - Royal Infirmary of Edinburgh
- • Glasgow - Queen Elizabeth Glasgow
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 65 Years - 91 Years
- Who can join: Female only
Biomarkers mentioned
What the study is looking for
- ✓Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age and less than 92 years...
- ✓Subject presents with a low-energy index fragility hip fracture in one hip and will undergo surgical repair of the...
- ✓Subject has at least one of the following additional risk factors for a secondary hip fracture (as determined by...
- ✓Documented falls assessment indicating subject is at moderate or high risk of falls
- ✓Falls history (2 or more falls in the previous 12 months)
Who cannot take part
- ✗Criterion omitted
- ✗Subject is currently enrolled in another interventional clinical study affecting the target hip.
- ✗Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the...
- ✗Subject has new fractures in addition to the index hip fracture at admission that, in the opinion of the...
- ✗Subject has an infection at the LOEP intended treatment site or has non-intact skin or acute traumatic injuries with...
See the full criteria
Where Is This Study? (6 UK sites)
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Queen Elizabeth Glasgow
Glasgow, United Kingdom
Wythenshawe Hospital Manchester
Manchester, United Kingdom
Nottingham University Hospitals, Queen's Medical Center
Nottingham, United Kingdom
How to Get in Touch
Charles Raymond
Sponsor contactCONTACT
