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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05338086
Other study ID # MB09-C-01-19
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 31, 2022
Est. completion date June 2024

Study information

Verified date April 2024
Source mAbxience Research S.L.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with osteoporosis


Description:

The study will randomise approximately 528 postmenopausal women with osteoporosis aged ≥55 and ≤80 years old with a Bone Mineral Density (BMD) consistent with T-score of ≤ -2.5 and ≥ -4 at the lumbar spine or hip as measured by DXA during the Screening Period. Screening evaluations will be completed within 28 days prior to randomisation. On Day 1, 528 eligible postmenopausal women with osteoporosis will be randomised in a 2:1:1 ratio to re-ceive MB09-MB09 (Arm 1), Prolia-MB09 (Arm 2), or Prolia-Prolia (Arm 3) using an Interactive Response Sys-tem (IRT). During the Main Treatment Period, subjects will receive one subcutaneous injection (60 mg/mL) of study drug on Day 1 and at Month 6. At Month 12, after all efficacy and safety assessments have been performed, the subject will enter the Transition/Safety Follow Up Period and will receive the third dose of study drug. Subjects assigned to the MB09 MB09 arm (Arm 1) will receive MB09 on Day 1, at Month 6 and at Month 12. Subjects assigned to the Prolia MB09 arm (Arm 2) will receive EU-Prolia on Day 1 and at Month 6, and MB09 at Month 12. Subjects assigned to the Prolia-Prolia arm (Arm 3) will receive EU-Prolia on Day 1, at Month 6, and at Month 12. All subjects will be followed up to Transition Period Month 6. All subjects will receive daily supplementation of calcium and vitamin D.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 528
Est. completion date June 2024
Est. primary completion date December 14, 2023
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 80 Years
Eligibility Inclusion Criteria: - Postmenopausal women, diagnosed with osteoporosis. - Aged = 55 and = 80 years at screening. - Body weight = 50 kg and = 99.9 kg, and a body mass index of =30 kg/m2 at screening. - Absolute bone mineral density consistent with T-score = -2.5 and = -4.0 at the lumbar spine or total hip as measured by DXA. - At least two intact, nonfractured vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA. - Adequate organ function. Exclusion Criteria: - Previous exposure to denosumab (Prolia®, Xgeva®, or denosumab biosimilar) or other monoclonal anti-body. - History and/or presence of one severe or more than two moderate vertebral fractures or hip fracture. - Recent long bone fracture (6 months). - History and/or presence of bone metastases, bone disease or other metabolic disease. - Ongoing use of any osteoporosis treatment or use of prohibited treatment. - Other bone active drugs. - History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or hypercalcemia. - Other Inclusion/exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MB09 (denosumab biosimilar)
PFS 60 mg/mL solution,
EU-Prolia
PFS 60 mg/mL solution, administered as subcutaneous injection
Dietary Supplement:
Elemental Calcium
at least 1000 mg daily
Vitamin D
at least 400 IU daily

Locations

Country Name City State
Bulgaria Medical Center Medconsult Pleven OOD Pleven
Bulgaria Medical Center Artmed OOD Plovdiv
Bulgaria Multiprofile Hospital for Active Treatment Plovdiv Plovdiv
Bulgaria Outpatient Clinic for Specialized Medical Help - Medical Center Kuchuk Paris "OOD" Plovdiv
Bulgaria AES - DRS - Medical Center Synexus Sofia EOOD Sofia Sofia-Grad
Bulgaria Diagnostic and Consulting Center Aleksandrovska EOOD Sofia
Bulgaria Diagnostic- Consultative Center Convex EOOD Sofia
Bulgaria Medical Center Excelsior OOD - PPDS Sofia
Bulgaria Medical Center Hera EOOD Sofia
Bulgaria Specialized outpatient medical facility - Rheumatology Centre St. Irina EOOD Sofia
Bulgaria University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Stara Zagora
Bulgaria New Medical Center EOOD Vratsa
Estonia KLV Arstikabinet Pärnu Pärnu Maakon
Estonia Center For Clinical And Basic Research Tallinn Harjumaa
Estonia East Tallinn Central Hospital Tallinn Harjumaa
Estonia North Estonia Medical Centre Foundation Tallinn Harjumaa
Estonia Clinical Research Centre Ltd Tartu Tartumaa
Estonia MediTrials OÜ Tartu Tartumaa
Estonia Tartu University Hospital Tartu Tartumaa
Georgia National Institute of Endocrinology Tbilisi
Georgia Tbilisi Heart and Vascular Clinic Ltd Tbilisi
Georgia Tbilisi Heart Center Ltd. Tbilisi
Hungary Bekes Megyei Kozponti Korhaz Békéscsaba Békés
Hungary AES - DRS - Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft Budapest
Hungary Óbudai Egészségügyi Centrum Kft Budapest
Hungary QUALICLINIC Kft Budapest
Hungary AES - DRS - Synexus Debrecen Magyarország Egészségügyi Szolgáltató Kft Debrecen Hajdú-Bihar
Hungary AES - DRS - Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft Gyula Békés
Hungary Pest Megyei Flór Ferenc Kórház Kistarcsa Pest
Hungary Csongrad Megyei Dr. Bugyi Istvan Korhaz Szentes Csongrád
Hungary MÁV Kórház és Rendelointézet Szolnok Szolnok Jász-Nagykun-Szolnok
Hungary Vital Medical Center Veszprém
Hungary AES - DRS - Synexus Zalaegerszeg Magyarország Egészségügyi Kft Zalaegerszeg Zala
Latvia Private Practice of Laila Atike Liepaja Liepajas Rajon
Latvia Outpatient Clinic Adoria Riga Rigas Rajons
Latvia Outpatient Clinic Veselibas Centrs 4 Riga Riga Rajon
Latvia RSU Ambulance Riga
Latvia Sigulda Hospital, Outpatient Clinic Sigulda Siguldas Pilseta
Mexico Hospital Angeles Lindavista (Consultorio de Reumatologia) Ciudad de Mexico Distrito Federal
Mexico Centro de Estudios de Investigacion Basica Y Clinica SC Guadalajara Jalisco
Mexico Hospital Universitario Dr. Jose Eleuterio González Monterrey Nuevo León
Mexico Centro Integral Medico SJR S.C Querétaro
Mexico Hospital Central Dr Ignacio Morones Prieto San Luis Potosí
Poland Bialystok - ClinicMed Daniluk, Nowak Spólka Jawna Bialystok Podlaskie
Poland NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik Bialystok Podlaskie
Poland Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy Bydgoszcz
Poland Centrum Medyczne Czestochowa - PRATIA - PPDS Czestochowa Slaskie
Poland Centrum Medyczne Katowice - PRATIA - PPDS Katowice
Poland Globe Badania Kliniczne Spólka z o.o. Klodzko Dolnoslaskie
Poland Krakowskie Centrum Medyczne Krakow
Poland Centrum Medyczne Linden Kraków
Poland MCM Krakow - PRATIA - PPDS Kraków
Poland AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu Poznan Wielkopolskie
Poland Lubelskie Centrum Diagnostyczne Swidnik Lubelskie
Poland Lubelskie Centrum Diagnostyczne (Lotników Polskich) Swidnik Lubelskie
Poland Centrum Medyczne AMED Warsaw
Poland Centrum Medyczne Reuma Park NZOZ Warsaw
Poland Rheuma Medicus Specjalistyczne Centrum Reumatologii i Osteoporozy Warsaw
Poland AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie Warszawa Mazowieckie
Poland AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu Wroclaw
Serbia Institute of Rheumatology Belgrade - PPDS Belgrad
Serbia Military Medical Academy Belgrad
Serbia University Clinical Center of Serbia - PPDS Belgrad
Serbia Clinical Centre of Vojvodina Novi Sad

Sponsors (1)

Lead Sponsor Collaborator
mAbxience Research S.L.

Countries where clinical trial is conducted

Bulgaria,  Estonia,  Georgia,  Hungary,  Latvia,  Mexico,  Poland,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage change from baseline in lumbar spine bone mineral density (BMD) at Month 12 Baseline and at Month 12
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