A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.

PHASE3CompletedINTERVENTIONAL
Enrollment

558

Participants

Timeline

Start Date

March 16, 2022

Primary Completion Date

December 14, 2023

Study Completion Date

May 22, 2024

Conditions
Postmenopausal Women With Osteoporosis
Interventions
DRUG

MB09 (denosumab biosimilar)

Pre-filled syringe (PFS) 60 mg/mL solution, administered as subcutaneous injection

DRUG

EU-Prolia

PFS 60 mg/mL solution, administered as subcutaneous injection

DIETARY_SUPPLEMENT

Elemental Calcium

at least 1000 mg daily

DIETARY_SUPPLEMENT

Vitamin D

at least 400 IU daily

Trial Locations (64)

Unknown

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

All Listed Sponsors
lead

mAbxience Research S.L.

INDUSTRY