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Preventing secondary hip fractures in postmenopausal women

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

Not applicable Interventional AgNovos Healthcare, LLC · NCT04796350

This study is testing if a new treatment can help prevent additional hip fractures in postmenopausal women who have already broken a hip and are having surgery to fix it.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment2400 (estimated)
Ages65 Years to 91 Years
SexFemale
SponsorAgNovos Healthcare, LLC Industry-sponsored
Locations66 sites (Innsbruck and 65 other locations)
Trial IDNCT04796350 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of AGN1 LOEP treatment in preventing secondary hip fractures in postmenopausal women who have experienced an index hip fracture and are undergoing surgical repair. Up to 2400 subjects will be randomly assigned to either receive the AGN1 LOEP treatment on the unfractured hip or serve as a control group without the treatment. Participants will be monitored for a minimum of 5 years through scheduled visits to assess the incidence of secondary fractures. The study aims to provide insights into the long-term benefits of AGN1 LOEP in this high-risk population.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women aged 65 and older with a low-energy index hip fracture and additional risk factors for secondary fractures.

Not a fit: Patients who do not have a history of fragility fractures or those who are not postmenopausal may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of secondary hip fractures in vulnerable postmenopausal women.

How similar studies have performed: Other studies have shown promise in similar approaches to fracture prevention, but the specific use of AGN1 LOEP is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Innsbruck and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Fragility FractureHip FracturesOsteoporosisHip FractureLOEPRESTORELocal osteo-enhancement procedure
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.