Recruiting

AGN1 LOEP

Sponsor:

AgNovos Healthcare, LLC

Code:

NCT04796350

Conditions

Fragility Fracture

Hip Fractures

Osteoporosis

Eligibility Criteria

Sex: Female

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

AGN1 LOEP treatment

Study Details

Brief 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.

Conditions

Fragility Fracture

Hip Fractures

Osteoporosis

Study ID

NCT04796350

Start date

Apr 24, 2021

Status verified date

May, 2026

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 65 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

AGN1 LOEP treatment

the implantation site is injected with the AGN1 implant material

Primary outcome measure

  • Cumulative incidence of secondary fragility hip fractures [ Time Frame: Interim Analysis, approximately 30 Months ]
  • Cumulative Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Interim Analysis, approximately 30 Months ]

Central Contacts and Locations

Central contacts

Locations

QEII Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada

Contacts

Sunnybrook Health Sciences Centre

Recruiting

North York, Ontario, Canada

Contacts

More Information

Sponsor

AgNovos Healthcare, LLC

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

  • Osteoporosis
  • Hip Fracture
  • Fragility Fracture
  • LOEP
  • RESTORE
  • Local osteo-enhancement procedure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by AgNovos Healthcare, LLC on 2026-05-13.