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

NCT05338086 | Completed Phase 3 Results DMC

• 1 other identifier: MB09-C-01-19
• Study Type: interventional
• Target: 558
• Locations: 8 countries
• Sites: 64

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

Conditions

Postmenopausal Women With Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (LS-BMD) at 52 Weeks - Modified Full Analysis Set (mFAS)

  To demonstrate equivalent efficacy of MB09 to EU Prolia in postmenopausal women with osteoporosis in terms of lumbar spine BMD at Week 52 (Month 12). The main analysis method was on the mFAS using a mixed model for repeated measures (MMRM) fitted to the composite %CfB lumbar spine BMD at Month 6 and Month 12, without any imputation of missing data. Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA) and assessments of the lumbar spine (L1 to L4) were performed at a central imaging vendor.

  Baseline (Screening), up to Week 52

Secondary Outcomes (10)

• Efficacy: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52 - Full Analysis Set (FAS)

  Baseline (screening), up to Week 52

• Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine at Month 6 and Total Hip and Femur Neck BMD at Month 6 and Month12 - MMRM on mFAS

  Baseline (screening), Month 6 and Month 12.

• Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine BMD at Month 6 and Total Hip and Femur Neck BMD at Month 6 and 12 - ANCOVA on FAS

  Baseline (screening), Month 6, Month 12.

• Pharmacodynamics: Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (sCTX) Area Under the Effect Curve From Zero to 6 Months (AUEC0-6 Months) After First Dose - Modified Full Analysis Set (mFAS)

  Baseline (pre-dose Day 1), up to Month 6.

• Pharmacodynamics: %CfB Area Under the Percent Inhibition Curve From Time Zero to 6 Months (AUIC0-6 Months) in sCTX - on mFAS

  Baseline (pre-dose Day 1), up to Month 6.

Study Arms (3)

MB09-MB09

EXPERIMENTAL

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

Drug: MB09 (denosumab biosimilar); Dietary Supplement: Elemental Calcium; Dietary Supplement: Vitamin D

Prolia-MB09

ACTIVE COMPARATOR

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

Drug: MB09 (denosumab biosimilar); Drug: EU-Prolia; Dietary Supplement: Elemental Calcium; Dietary Supplement: Vitamin D

Prolia-Prolia

ACTIVE COMPARATOR

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

Drug: EU-Prolia; Dietary Supplement: Elemental Calcium; Dietary Supplement: Vitamin D

Interventions

MB09 (denosumab biosimilar) DRUG

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

MB09-MB09; Prolia-MB09

EU-Prolia DRUG

PFS 60 mg/mL solution, administered as subcutaneous injection

Prolia-MB09; Prolia-Prolia

Elemental Calcium DIETARY_SUPPLEMENT

at least 1000 mg daily

MB09-MB09; Prolia-MB09; Prolia-Prolia

Vitamin D DIETARY_SUPPLEMENT

at least 400 IU daily

MB09-MB09; Prolia-MB09; Prolia-Prolia

Eligibility Criteria

• Age: 55 Years - 80 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• mAbxience Research S.L.: lead

Study Sites (64)

AES - DRS - Medical Center Synexus Sofia EOOD

Sofia, Sofia-Grad, Bulgaria

Location

Medical Center Medconsult Pleven OOD

Pleven, Bulgaria

Location

Medical Center Artmed OOD

Plovdiv, Bulgaria

Location

Multiprofile Hospital for Active Treatment Plovdiv

Plovdiv, Bulgaria

Location

Outpatient Clinic for Specialized Medical Help - Medical Center Kuchuk Paris "OOD"

Plovdiv, Bulgaria

Location

Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, Bulgaria

Location

Diagnostic- Consultative Center Convex EOOD

Sofia, Bulgaria

Location

Medical Center Excelsior OOD - PPDS

Sofia, Bulgaria

Location

Medical Center Hera EOOD

Sofia, Bulgaria

Location

Specialized outpatient medical facility - Rheumatology Centre St. Irina EOOD

Sofia, Bulgaria

Location

University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD

Stara Zagora, Bulgaria

Location

New Medical Center EOOD

Vratsa, Bulgaria

Location

Center For Clinical And Basic Research

Tallinn, Harju, Estonia

Location

East Tallinn Central Hospital

Tallinn, Harju, Estonia

Location

North Estonia Medical Centre Foundation

Tallinn, Harju, Estonia

Location

KLV Arstikabinet

Pärnu, Pärnu Maakon, Estonia

Location

Clinical Research Centre Ltd

Tartu, Tartu, Estonia

Location

MediTrials OÜ

Tartu, Tartu, Estonia

Location

Tartu University Hospital

Tartu, Tartu, Estonia

Location

National Institute of Endocrinology

Tbilisi, Georgia

Location

Tbilisi Heart and Vascular Clinic Ltd

Tbilisi, Georgia

Location

Tbilisi Heart Center Ltd.

Tbilisi, Georgia

Location

Bekes Megyei Kozponti Korhaz

Békéscsaba, Bekes County, Hungary

Location

AES - DRS - Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft

Gyula, Bekes County, Hungary

Location

Csongrad Megyei Dr. Bugyi Istvan Korhaz

Szentes, Csongrád megye, Hungary

Location

AES - DRS - Synexus Debrecen Magyarország Egészségügyi Szolgáltató Kft

Debrecen, Hajdú-Bihar, Hungary

Location

MÁV Kórház és Rendelointézet Szolnok

Szolnok, Jász-Nagykun-Szolnok, Hungary

Location

Pest Megyei Flór Ferenc Kórház

Kistarcsa, Pest County, Hungary

Location

AES - DRS - Synexus Zalaegerszeg Magyarország Egészségügyi Kft

Zalaegerszeg, Zala County, Hungary

Location

AES - DRS - Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft

Budapest, Hungary

Location

QUALICLINIC Kft

Budapest, Hungary

Location

Óbudai Egészségügyi Centrum Kft

Budapest, Hungary

Location

Vital Medical Center

Veszprém, Hungary

Location

Private Practice of Laila Atike

Liepāja, Liepājas Rajon, Latvia

Location

Outpatient Clinic Veselibas Centrs 4

Riga, Riga Rajon, Latvia

Location

Outpatient Clinic Adoria

Riga, Rigas Rajons, Latvia

Location

Sigulda Hospital, Outpatient Clinic

Sigulda, Siguldas Pilsēta, Latvia

Location

RSU Ambulance

Riga, Latvia

Location

Centro de Estudios de Investigacion Basica Y Clinica SC

Guadalajara, Jalisco, Mexico

Location

Hospital Angeles Lindavista (Consultorio de Reumatologia)

Mexico City, Mexico City, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio González

Monterrey, Nuevo León, Mexico

Location

Centro Integral Medico SJR S.C

Querétaro, Mexico

Location

Hospital Central Dr Ignacio Morones Prieto

San Luis Potosí City, Mexico

Location

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

Poznan, Greater Poland Voivodeship, Poland

Location

Globe Badania Kliniczne Spólka z o.o.

Kłodzko, Lower Silesian Voivodeship, Poland

Location

Lubelskie Centrum Diagnostyczne (Lotników Polskich)

Świdnik, Lublin Voivodeship, Poland

Location

Lubelskie Centrum Diagnostyczne

Świdnik, Lublin Voivodeship, Poland

Location

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

Warsaw, Masovian Voivodeship, Poland

Location

Bialystok - ClinicMed Daniluk, Nowak Spólka Jawna

Bialystok, Podlaskie Voivodeship, Poland

Location

NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik

Bialystok, Podlaskie Voivodeship, Poland

Location

Centrum Medyczne Czestochowa - PRATIA - PPDS

Częstochowa, Silesian Voivodeship, Poland

Location

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, Poland

Location

Centrum Medyczne Katowice - PRATIA - PPDS

Katowice, Poland

Location

Centrum Medyczne Linden

Krakow, Poland

Location

Krakowskie Centrum Medyczne

Krakow, Poland

Location

MCM Krakow - PRATIA - PPDS

Krakow, Poland

Location

Centrum Medyczne AMED

Warsaw, Poland

Location

Centrum Medyczne Reuma Park NZOZ

Warsaw, Poland

Location

Rheuma Medicus Specjalistyczne Centrum Reumatologii i Osteoporozy

Warsaw, Poland

Location

AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

Wroclaw, Poland

Location

Institute of Rheumatology Belgrade - PPDS

Belgrade, Serbia

Location

Military Medical Academy

Belgrade, Serbia

Location

University Clinical Center of Serbia - PPDS

Belgrade, Serbia

Location

Clinical Centre of Vojvodina

Novi Sad, Serbia

Location

MeSH Terms

Interventions

Calcium; Vitamin D

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Susana Millan , PhD
• Organization: mAbxience Research S.L.

Susana.Millan@mabxience.com

(+34) 917.711.500

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 20, 2022
• Study Start: March 16, 2022
• Primary Completion: December 14, 2023
• Study Completion: May 22, 2024
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2024-12

Locations

PL (17); HU (11); ME (5); ES (7); BU (12); LA (5); GE (3); SE (4)