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New procedure aims to stop repeat hip fractures in osteoporosis patients

NCT ID NCT04796350

Prevention Sponsor: AgNovos Healthcare, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a procedure called LOEP that strengthens the hip bone to prevent a second fracture in women over 65 with osteoporosis who have already broken one hip. About 2400 women will either receive the procedure or standard care and be followed for at least 5 years. The goal is to see if LOEP reduces the risk of another hip fracture on the treated side.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 91 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hip fracture osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fragility fracture Hip fractures Osteoporosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    48 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Gaetano Pini CTO

    RECRUITING

    Milan, Italy

  • Aarhus University Hospital

    RECRUITING

    Aarhus, Denmark

  • Akita City Hospital

    RECRUITING

    Akita, Akita, Japan

  • Azienda Ospedaliero Universitaria Careggi

    RECRUITING

    Florence, Italy

  • BG Klinik Tuebingen

    ACTIVE_NOT_RECRUITING

    Tübingen, Germany

  • Birmingham Heartlands Hospital

    WITHDRAWN

    Birmingham, England, United Kingdom

  • CHU Amiens

    RECRUITING

    Amiens, France

  • CHU Grenoble-Alpes

    RECRUITING

    Grenoble, France

  • CHU Lyon

    WITHDRAWN

    Lyon, France

  • CHU Toulouse

    WITHDRAWN

    Toulouse, France

  • CHU de Nice

    RECRUITING

    Nice, Provence-Alpes-Côte d'Azur Region, France

  • CTO Torino

    RECRUITING

    Torino, Italy

  • Charite University Hosptial

    RECRUITING

    Berlin, Germany

  • Chikamori Hospital

    ACTIVE_NOT_RECRUITING

    Kochi, Kochi, Japan

  • Clinic de Barcelona

    RECRUITING

    Barcelona, Spain

  • Deventer Hospital

    RECRUITING

    Deventer, Netherlands

  • Galdakao-Usansolo Hospital

    RECRUITING

    Galdakao, Spain

  • Ghent University Hospital

    RECRUITING

    Ghent, Belgium

  • Health Sciences Centre - Eastern Health

    WITHDRAWN

    St. John's, Newfoundland and Labrador, Canada

  • Helios Wuppertal

    ACTIVE_NOT_RECRUITING

    Wuppertal, Germany

  • Hospital Clínico San Carlos

    RECRUITING

    Madrid, Spain

  • Hospital Neuro-Traumatológico de Jaén

    RECRUITING

    Jaén, Spain

  • Hospital St Joan de Deu

    RECRUITING

    Manresa, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Infanta Leonor

    RECRUITING

    Madrid, Spain

  • Hospital Universitario de Basurto

    RECRUITING

    Bilbao, Spain

  • Hyogo Prefectural Nishinomiya Hospital

    RECRUITING

    Nishinomiya, Hyōgo, Japan

  • Innsbruck Hospital

    RECRUITING

    Innsbruck, Austria

  • Isala Hospital

    ACTIVE_NOT_RECRUITING

    Zwolle, Netherlands

  • Iwata City Hospital

    RECRUITING

    Iwata, Japan

  • Japanese Red Cross Shizuoka Hospital

    RECRUITING

    Shizuoka, Japan

  • Justus Liebig Universitat Gießen

    WITHDRAWN

    Giessen, Germany

  • Jutendo University Shizuoka Hospital

    WITHDRAWN

    Izunokuni, Shizuoka, Japan

  • Kagawa Rosai Hospital

    RECRUITING

    Marugame, Kagawa-ken, Japan

  • Kanto Rosai Hospital

    RECRUITING

    Kawasaki, Kanagawa, Japan

  • Klinikum der Universität München

    RECRUITING

    München, Germany

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, England, United Kingdom

  • Maastricht UMC

    RECRUITING

    Maastricht, Netherlands

  • Medizinische Hochschule Hannover

    ACTIVE_NOT_RECRUITING

    Hanover, Germany

  • Mutua de Terrassa University Hospital

    RECRUITING

    Terrassa, Spain

  • National Hospital Organization Kumamoto Medical Center

    RECRUITING

    Kumamoto, Japan

  • Nottingham University Hospitals, Queen's Medical Center

    RECRUITING

    Nottingham, United Kingdom

  • Okayama Medical Center

    RECRUITING

    Okayama, Okayama-ken, Japan

  • PARC Tauli

    ACTIVE_NOT_RECRUITING

    Sabadell, Spain

  • Policlinico Tor Vergata

    RECRUITING

    Rome, Italy

  • QEII Health Sciences Centre

    RECRUITING

    Halifax, Nova Scotia, Canada

  • Queen Elizabeth Glasgow

    RECRUITING

    Glasgow, United Kingdom

  • Royal Infirmary of Edinburgh

    RECRUITING

    Edinburgh, Scotland, United Kingdom

  • Saga-Ken Medical Centre Koseikan

    RECRUITING

    Saga, Japan

  • Saint Anna Ziekenhuis

    WITHDRAWN

    Geldrop, Netherlands

  • Shin-Yurigaoka General Hospital

    RECRUITING

    Kawasaki-shi, Japan

  • Southern Tohoku General Hospital

    RECRUITING

    Kōriyama, Fukushima, Japan

  • St. Mary's Hospital

    RECRUITING

    Fukuoka, Japan

  • Sunnybrook Health Sciences Centre

    RECRUITING

    North York, Ontario, Canada

  • The University of Tokyo Hospital

    WITHDRAWN

    Bunkyō-Ku, Tokyo, Japan

  • UZ Leuven

    RECRUITING

    Leuven, Belgium

  • Universitatsklinikum Schleswig-Holstein

    RECRUITING

    Kiel, Germany

  • University Hospital San Raffaele Milano

    WITHDRAWN

    Milan, Italy

  • University Hospital of Duesseldorf

    ACTIVE_NOT_RECRUITING

    Düsseldorf, Germany

  • University Hospital of Münster

    WITHDRAWN

    Münster, Germany

  • Universitätsklinikum Regensburg

    WITHDRAWN

    Regensburg, Germany

  • Vall d'Hebron University Hospital

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Valladolid University Clinic Hospital

    RECRUITING

    Valladolid, Valladolid, 47003, Spain

  • Vitaz Sint-Niklaas

    RECRUITING

    Sint-Niklaas, Belgium

  • Wythenshawe Hospital Manchester

    RECRUITING

    Manchester, United Kingdom

  • Ziekenhuis Oost-Limburg

    RECRUITING

    Genk, Belgium

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