Phase 3
N=558
A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.
Postmenopausal Women With Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT05338086 ↗Enrolled (actual)
558
Serious AEs
6.1%
Results posted
Mar 2025
Primary outcome: Primary: Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (LS-BMD) at 52 Weeks - Modified Full Analysis Set (mFAS) — 5.86; 5.66 Percentage change (%)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MB09 (denosumab biosimilar) (Drug); EU-Prolia (Drug); Elemental Calcium (Dietary_supplement); Vitamin D (Dietary_supplement)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- mAbxience Research S.L.
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (LS-BMD) at 52 Weeks - Modified Full Analysis Set (mFAS) |
5.86; 5.66 | — |
| SECONDARY Efficacy: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52 - Full Analysis Set (FAS) |
5.40; 5.38 | — |
| SECONDARY 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 |
3.37; 3.28; 2.75; 2.39; 4.03; 3.96 | — |
| SECONDARY 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 |
3.31; 3.27; 2.70; 2.38; 3.82; 3.92 | — |
| SECONDARY 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) |
12300; 12400 | — |
| SECONDARY Pharmacodynamics: %CfB Area Under the Percent Inhibition Curve From Time Zero to 6 Months (AUIC0-6 Months) in sCTX - on mFAS |
15100; 15300 | — |
| SECONDARY Pharmacokinetics: Maximum Observed Serum Concentration (Cmax) of Denosumab After First Dose Study Treatment (Pharmacokinetic Parameter Analysis Set) |
5960; 5700 | — |
| SECONDARY Pharmacokinetics: To Assess the PK Profile of MB09 Compared With EU Prolia (AUC0-6 Months) Following the First Dose |
360,000; 337000 | — |
| SECONDARY Safety: Overall Summary of Adverse Events - Main Treatment Period - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP) |
161; 150; 180; 87; 75; 41 | — |
| SECONDARY Safety: New Clinical Bone Fractures - TEAEs (Throughout the Study - From Day 1 Untill Month 18) |
12; 6; 4; 3; 2; 1 | — |
| SECONDARY Overall Incidence of Antidrug Antibodies (ADA) - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP) |
1; 3; 3; 0; 0; 0 | — |
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
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.
- Other Inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05338086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.