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

NCT ID: NCT05338086

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 558 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-16
• Study Completion Date: 2024-05-22

Brief Summary

This was 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

Detailed Description

The study was planning to 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 total hip as measured by DXA during the Screening Period. Screening evaluations were to be completed within 28 days prior to randomisation.

On Day 1, 528 eligible postmenopausal women with osteoporosis were to be randomised in a 2:1:1 ratio to receive 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 received 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 were to be enter the Transition/Safety Follow Up Period and were to receive the third dose of study drug. Subjects assigned to the MB09 MB09 arm (Arm 1) received MB09 on Day 1, at Month 6 and at Month 12. Subjects assigned to the Prolia MB09 arm (Arm 2) received EU-Prolia on Day 1 and at Month 6, and MB09 at Month 12. Subjects assigned to the Prolia-Prolia arm (Arm 3) received EU-Prolia on Day 1, at Month 6, and at Month 12. All subjects were to be followed up to Transition Period Month 6.

All subjects received daily supplementation of calcium and vitamin D.

Conditions

Postmenopausal Women With Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MB09-MB09

Subjects randomised into MB09-MB09 group were administered MB09 (60 mg in 1 mL) SC injection every 6 months.

Group Type: EXPERIMENTAL

MB09 (denosumab biosimilar)

Intervention Type: DRUG

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

Elemental Calcium

Intervention Type: DIETARY_SUPPLEMENT

at least 1000 mg daily

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

at least 400 IU daily

Prolia-MB09

Subjects randomised into Prolia- MB09 group were administered Prolia® (60 mg in 1 mL) SC injection every 6 months.

Group Type: ACTIVE_COMPARATOR

MB09 (denosumab biosimilar)

Intervention Type: DRUG

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

EU-Prolia

Intervention Type: DRUG

PFS 60 mg/mL solution, administered as subcutaneous injection

Elemental Calcium

Intervention Type: DIETARY_SUPPLEMENT

at least 1000 mg daily

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

at least 400 IU daily

Prolia-Prolia

Subjects randomised into Prolia-Prolia group were administered Prolia® (60 mg in 1 mL) SC injection every 6 months.

Group Type: ACTIVE_COMPARATOR

EU-Prolia

Intervention Type: DRUG

PFS 60 mg/mL solution, administered as subcutaneous injection

Elemental Calcium

Intervention Type: DIETARY_SUPPLEMENT

at least 1000 mg daily

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

at least 400 IU daily

Interventions

MB09 (denosumab biosimilar)

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

Intervention Type: DRUG

EU-Prolia

PFS 60 mg/mL solution, administered as subcutaneous injection

Intervention Type: DRUG

Elemental Calcium

at least 1000 mg daily

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D

at least 400 IU daily

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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 Dual-energy X-ray Absorptiometry (DXA).
• At least two intact, nonfractured vertebrae in the L1-L4 region and at least one hip joint evaluable by DXA.
• Adequate organ function.

Exclusion Criteria

• Previous exposure to denosumab (Prolia®, Xgeva®, or denosumab biosimilar) or other monoclonal antibody.
• History and/or presence of one severe or more than two moderate vertebral fractures or hip fracture.
• Recent long bone fracture (within 6 months).
• History and/or presence of bone metastases, bone disease or other metabolic disease.
• Intravenous bisphosphonate administered within 5 years of screening.
• Oral bisphosphonates ≥12 months cumulative use prior to screening. If used <12 months cumulatively and the last dose was ≥12 months before screening, the subject could be enrolled.
• 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

mAbxience Research S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AES - DRS - Medical Center Synexus Sofia EOOD

Sofia, Sofia-Grad, 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

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, , Bulgaria

Center For Clinical And Basic Research

Tallinn, Harju, Estonia

East Tallinn Central Hospital

Tallinn, Harju, Estonia

North Estonia Medical Centre Foundation

Tallinn, Harju, Estonia

KLV Arstikabinet

Pärnu, Pärnu Maakon, Estonia

Clinical Research Centre Ltd

Tartu, Tartu, Estonia

MediTrials OÜ

Tartu, Tartu, Estonia

Tartu University Hospital

Tartu, Tartu, Estonia

National Institute of Endocrinology

Tbilisi, , Georgia

Tbilisi Heart and Vascular Clinic Ltd

Tbilisi, , Georgia

Tbilisi Heart Center Ltd.

Tbilisi, , Georgia

Bekes Megyei Kozponti Korhaz

Békéscsaba, Bekes County, Hungary

AES - DRS - Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft

Gyula, Bekes County, Hungary

Csongrad Megyei Dr. Bugyi Istvan Korhaz

Szentes, Csongrád megye, Hungary

AES - DRS - Synexus Debrecen Magyarország Egészségügyi Szolgáltató Kft

Debrecen, Hajdú-Bihar, Hungary

MÁV Kórház és Rendelointézet Szolnok

Szolnok, Jász-Nagykun-Szolnok, Hungary

Pest Megyei Flór Ferenc Kórház

Kistarcsa, Pest County, Hungary

AES - DRS - Synexus Zalaegerszeg Magyarország Egészségügyi Kft

Zalaegerszeg, Zala County, Hungary

AES - DRS - Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft

Budapest, , Hungary

QUALICLINIC Kft

Budapest, , Hungary

Óbudai Egészségügyi Centrum Kft

Budapest, , Hungary

Vital Medical Center

Veszprém, , Hungary

Private Practice of Laila Atike

Liepāja, Liepājas Rajon, Latvia

Outpatient Clinic Veselibas Centrs 4

Riga, Riga Rajon, Latvia

Outpatient Clinic Adoria

Riga, Rigas Rajons, Latvia

Sigulda Hospital, Outpatient Clinic

Sigulda, Siguldas Pilsēta, Latvia

RSU Ambulance

Riga, , Latvia

Centro de Estudios de Investigacion Basica Y Clinica SC

Guadalajara, Jalisco, Mexico

Hospital Angeles Lindavista (Consultorio de Reumatologia)

Mexico City, Mexico City, 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 City, , Mexico

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

Poznan, Greater Poland Voivodeship, Poland

Globe Badania Kliniczne Spólka z o.o.

Kłodzko, Lower Silesian Voivodeship, Poland

Lubelskie Centrum Diagnostyczne (Lotników Polskich)

Świdnik, Lublin Voivodeship, Poland

Lubelskie Centrum Diagnostyczne

Świdnik, Lublin Voivodeship, Poland

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie

Warsaw, Masovian Voivodeship, Poland

Bialystok - ClinicMed Daniluk, Nowak Spólka Jawna

Bialystok, Podlaskie Voivodeship, Poland

NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik

Bialystok, Podlaskie Voivodeship, Poland

Centrum Medyczne Czestochowa - PRATIA - PPDS

Częstochowa, Silesian Voivodeship, Poland

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, , Poland

Centrum Medyczne Katowice - PRATIA - PPDS

Katowice, , Poland

Centrum Medyczne Linden

Krakow, , Poland

Krakowskie Centrum Medyczne

Krakow, , Poland

MCM Krakow - PRATIA - PPDS

Krakow, , 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 we Wroclawiu

Wroclaw, , Poland

Institute of Rheumatology Belgrade - PPDS

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

University Clinical Center of Serbia - PPDS

Belgrade, , Serbia

Clinical Centre of Vojvodina

Novi Sad, , Serbia

Countries

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

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MB09-C-01-19

Identifier Type: -

Identifier Source: org_study_id