558
Participants
Start Date
March 16, 2022
Primary Completion Date
December 14, 2023
Study Completion Date
May 22, 2024
MB09 (denosumab biosimilar)
Pre-filled syringe (PFS) 60 mg/mL solution, administered as subcutaneous injection
EU-Prolia
PFS 60 mg/mL solution, administered as subcutaneous injection
Elemental Calcium
at least 1000 mg daily
Vitamin D
at least 400 IU daily
AES - DRS - Medical Center Synexus Sofia EOOD, Sofia
Medical Center Medconsult Pleven OOD, Pleven
Medical Center Artmed OOD, Plovdiv
Multiprofile Hospital for Active Treatment Plovdiv, Plovdiv
"Outpatient Clinic for Specialized Medical Help - Medical Center Kuchuk Paris OOD", Plovdiv
Diagnostic and Consulting Center Aleksandrovska EOOD, Sofia
Diagnostic- Consultative Center Convex EOOD, Sofia
Medical Center Excelsior OOD - PPDS, Sofia
Medical Center Hera EOOD, Sofia
Specialized outpatient medical facility - Rheumatology Centre St. Irina EOOD, Sofia
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD, Stara Zagora
New Medical Center EOOD, Vratsa
Center For Clinical And Basic Research, Tallinn
East Tallinn Central Hospital, Tallinn
North Estonia Medical Centre Foundation, Tallinn
KLV Arstikabinet, Pärnu
Clinical Research Centre Ltd, Tartu
MediTrials OÜ, Tartu
Tartu University Hospital, Tartu
National Institute of Endocrinology, Tbilisi
Tbilisi Heart and Vascular Clinic Ltd, Tbilisi
Tbilisi Heart Center Ltd., Tbilisi
Bekes Megyei Kozponti Korhaz, Békéscsaba
AES - DRS - Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft, Gyula
Csongrad Megyei Dr. Bugyi Istvan Korhaz, Szentes
AES - DRS - Synexus Debrecen Magyarország Egészségügyi Szolgáltató Kft, Debrecen
MÁV Kórház és Rendelointézet Szolnok, Szolnok
Pest Megyei Flór Ferenc Kórház, Kistarcsa
AES - DRS - Synexus Zalaegerszeg Magyarország Egészségügyi Kft, Zalaegerszeg
AES - DRS - Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft, Budapest
QUALICLINIC Kft, Budapest
Óbudai Egészségügyi Centrum Kft, Budapest
Vital Medical Center, Veszprém
Private Practice of Laila Atike, Liepāja
Outpatient Clinic Veselibas Centrs 4, Riga
Outpatient Clinic Adoria, Riga
Sigulda Hospital, Outpatient Clinic, Sigulda
RSU Ambulance, Riga
Centro de Estudios de Investigacion Basica Y Clinica SC, Guadalajara
Hospital Angeles Lindavista (Consultorio de Reumatologia), Mexico City
Hospital Universitario Dr. Jose Eleuterio González, Monterrey
Centro Integral Medico SJR S.C, Querétaro
Hospital Central Dr Ignacio Morones Prieto, San Luis Potosí City
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu, Poznan
Globe Badania Kliniczne Spólka z o.o., Kłodzko
Lubelskie Centrum Diagnostyczne (Lotników Polskich), Świdnik
Lubelskie Centrum Diagnostyczne, Świdnik
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warsaw
Bialystok - ClinicMed Daniluk, Nowak Spólka Jawna, Bialystok
NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik, Bialystok
Centrum Medyczne Czestochowa - PRATIA - PPDS, Częstochowa
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz
Centrum Medyczne Katowice - PRATIA - PPDS, Katowice
Centrum Medyczne Linden, Krakow
Krakowskie Centrum Medyczne, Krakow
MCM Krakow - PRATIA - PPDS, Krakow
Centrum Medyczne AMED, Warsaw
Centrum Medyczne Reuma Park NZOZ, Warsaw
Rheuma Medicus Specjalistyczne Centrum Reumatologii i Osteoporozy, Warsaw
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Wroclaw
Institute of Rheumatology Belgrade - PPDS, Belgrade
Military Medical Academy, Belgrade
University Clinical Center of Serbia - PPDS, Belgrade
Clinical Centre of Vojvodina, Novi Sad
mAbxience Research S.L.
INDUSTRY