Osteoporosis Clinical Trial
Official title:
Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures
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.
Status | Recruiting |
Enrollment | 2400 |
Est. completion date | April 1, 2029 |
Est. primary completion date | April 1, 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: 1. Subject is a postmenopausal female at least 1-year post menses and at least 65 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 or moderate cognitive impairment) 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. 5. Informed consent is provided by the subject or the subject's LAR. 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. Subject hospital admission is > 24 hours from the time of the index hip fracture. 2. Subject was dependent on the use of a wheelchair or was bedridden prior to the index hip fracture. 3. Subject is currently enrolled in another clinical study. 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 one or more new fractures in addition to the index hip fracture at admission that, in the opinion of the investigator, would further compromise patient mobility, rehabilitation, and/or recovery or subject has three or more new fractures in addition to the index hip fracture. 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. Subject is at ASA Class IV, V, or VI. 10. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia). 11. Subject has a history of Pott's disease. 12. Subject has a history of any invasive malignancy (except nonmelanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years. 13. Subject has chronic cardiac insufficiency or severe cardiovascular disease as assessed by a subject or LAR interview to be NYHA Class III or IV or has an implanted pacemaker. 14. Subject has a history of cardiovascular events (e.g. stroke, transient ischemic attack, myocardial infarction, unstable angina, pulmonary embolus, deep vein thrombosis, ventricular tachycardia, or atrial fibrillation) in the last 3 months. 15. Subject is on oral or parenteral immuno-suppressive drugs. 16. Subject has uncontrolled diabetes mellitus. 17. Subject has Hb = 9 g/dL at admission. 18. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) = 30 mL/min. 19. Subject has a diagnosed and ongoing calcium metabolism disorder. 20. Subject has a Parker Mobility Score = 5. 21. Subject has severe cognitive impairment as assessed by SPMSQ. 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., inability to maintain follow-up schedule, comorbidity or poor general physical/mental health, or drug or alcohol abuse issues). 24. Subject fails pre-operative or intraoperative eligibility criteria as specified in section 7.4.2. of the clinical investigation plan. |
Country | Name | City | State |
---|---|---|---|
Austria | Innsbruck Hospital | Innsbruck | |
Denmark | Aarhus University Hospital | Aarhus | |
France | CHU Grenoble-Alpes | Grenoble | |
France | CHU Lyon | Lyon | |
France | CHU Toulouse | Toulouse | |
Germany | University Hospital of Duesseldorf | Düsseldorf | |
Germany | Justus Liebig Universitat Gießen | Gießen | |
Germany | Medizinische Hochschule Hannover | Hannover | |
Germany | Universitatsklinikum Schleswig-Holstein | Kiel | |
Germany | Klinikum der Universität München | München | |
Germany | University Hospital of Münster | Münster | |
Germany | Universitätsklinikum Regensburg | Regensburg | |
Germany | BG Klinik Tuebingen | Tuebingen | |
Italy | Azienda Ospedaliero Universitaria Careggi | Firenze | |
Italy | ASST Gaetano Pini CTO | Milano | |
Italy | University Hospital San Raffaele Milano | Milano | |
Italy | Policlinico Tor Vergata | Rome | |
Japan | Akita City Hospital | Akita-shi | Akita |
Japan | The University of Tokyo Hospital | Bunkyo-Ku | Tokyo |
Japan | St. Mary's Hospital | Fukuoka | |
Japan | Iwata City Hospital | Iwata | |
Japan | Jutendo University Shizuoka Hospital | Izunokuni City | Shizuoka |
Japan | Kanto Rosai Hospital | Kawasaki City | Kanagawa |
Japan | Shin-yurigaoka General Hospital | Kawasaki-Shi | Kanagawa |
Japan | Shin-Yurigaoka General Hospital | Kawasaki-shi | |
Japan | Southern Tohoku General Hospital | Koriyama | Fukushima |
Japan | Chikamori Hospital | Kouchi City | Kochi |
Japan | National Hospital Organization Kumamoto Medical Center | Kumamoto | |
Japan | Kagawa Rosai Hospital | Marugame | Kagawa |
Japan | Hyogo Prefectural Nishinomiya Hospital | Nishinomiya | Hyogo |
Japan | Okayama Medical Center | Okayama City | Okayama |
Japan | Saga-Ken Medical Centre Koseikan | Saga | |
Japan | Japanese Red Cross Shizuoka Hospital | Shizuoka | |
Netherlands | Deventer Hospital | Deventer | |
Netherlands | Saint Anna Ziekenhuis | Geldrop | |
Netherlands | Maastricht UMC | Maastricht | |
Netherlands | Isala Hospital | Zwolle | |
Spain | Clinic de Barcelona | Barcelona | |
Spain | Vall d'Hebron University Hospital | Barcelona | |
Spain | Hospital Universitario de Basurto | Bilbao | |
Spain | Galdakao-Usansolo Hospital | Galdakao | |
Spain | Hospital Neuro-Traumatológico de Jaén | Jaén | |
Spain | Hospital Clínico San Carlos | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | PARC Tauli | Sabadell | |
Spain | Mutua de Terrassa University Hospital | Terrassa | |
Spain | Valladolid University Clinic Hospital | Valladolid | |
United Kingdom | Birmingham Heartlands Hospital | Birmingham | England |
United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | Scotland |
United Kingdom | Leicester Royal Infirmary | Leicester | England |
United Kingdom | Nottingham University Hospitals, Queen's Medical Center | Nottingham |
Lead Sponsor | Collaborator |
---|---|
AgNovos Healthcare, LLC | Avania, BioClinica, Inc., CMIC Co, Ltd. Japan, Emergent Clinical Consulting, LLC |
Austria, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative incidence of secondary fragility hip fractures | Comparison of incidence of secondary fragility hip fractures in the target hip among the Treated Group vs. Control Group. | Interim Analysis, approximately 30 Months | |
Primary | Cumulative Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Comparison of incidence of AEs and SAEs among the Treated Group vs. Control Group. | Interim Analysis, approximately 30 Months | |
Secondary | Areal bone mineral density (aBMD) | Total hip areal bone mineral density in target hips of the Treated Group compared to the Control Group | 12 months and 24 months | |
Secondary | Trabecular Bone Score (TBS) | Continuous densitometry measure of the target hip bone of the Treated Group compared to the Control Group | 12 months and 24 months |
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