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CompletedNCT05338086Updated Mar 21, 2025Results posted

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

A Phase 3 interventional study of MB09 (denosumab biosimilar) and EU-Prolia in Postmenopausal Women With Osteoporosis, sponsored by mAbxience Research S.L.. Completed at 64 sites in 8 countries. Open to female participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by mAbxience Research S.L. (part of Fresenius Kabi) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
558
Allocation
Randomized
Ages
55 Years to 80 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Postmenopausal Women With Osteoporosis

Browse trials for

03

In context

Osteoporosis

1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.

This study's enrollment of 558 is above the median of 88 across 1,084 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

mAbxience Research S.L. is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

First submitted before mAbxience Research S.L. became part of Fresenius Kabi.

Browse mAbxience Research S.L. studies →All Fresenius Kabi studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women, diagnosed with osteoporosis.
  • Aged ≥ 55 and ≤ 80 years at screening.
  • Body weight ≥ 50 kg and ≤ 99.9 kg, and a 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

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 , 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
558 participants (actual)

Study arms

  • Experimental
    MB09-MB09

    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

  • Active comparator
    Prolia-MB09

    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

  • Active comparator
    Prolia-Prolia

    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

  • DrugMB09 (denosumab biosimilar)

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

  • DrugEU-Prolia

    PFS 60 mg/mL solution, administered as subcutaneous injection

  • Dietary supplementElemental Calcium

    at least 1000 mg daily

  • Dietary supplementVitamin D

    at least 400 IU daily

06

What researchers measure

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.

    Time frame: Baseline (Screening), up to Week 52

Secondary outcomes

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

    Difference in means (MB09-Prolia) in the %CfB in lumbar spine BMD after 12 months in postmenopausal women with osteoporosis treated with SC denosumab injections every 6 months. This included all subjects and data records irrespective of failed eligibility criteria, receipt of prohibited medications, discontinued treatment for any reason, had errors or deviations in dosing, or receipt of both doses. Estimation was via Multiple Imputation (MI) and ANCOVA on the FAS. Since the retrieved dropout rate was low, a treatment-failure (TF) penalty was applied to the imputed values at Month 12 for those subjects who received only one dose of the study treatment to centre the distribution of each subject's %CfB values around their baseline level. Bone density measurements were performed by DXA. All DXA scans were submitted to a central imaging vendor for analysis.

    Time frame: Baseline (screening), up to Week 52

  2. 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

    To assess the efficacy of MB09 to EU-Prolia in postmenopausal women with osteoporosis in terms of Lumbar Spine at Month 6 and Total Hip and Femur Neck BMD at Month 6 and Month12. The difference in means in %CfB in lumbar spine BMD between MB09 and Prolia at Month 6 and Total Hip and Femur Neck at Month 6 and Month 12 from an MMRM presented for the mFAS. Bone density measurements were performed by DXA. All DXA scans were submitted to a central imaging vendor for analysis.

    Time frame: Baseline (screening), Month 6 and Month 12.

  3. 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

    To assess the efficacy of MB09 to EU-Prolia in postmenopausal women with osteoporosis in terms of the difference in means (MB09-Prolia) in the %CfB in Lumbar Spine BMD at Month 6 and Total Hip and Femur Neck BMD at Month 6 and 12 in postmenopausal women with osteoporosis treated with SC denosumab injections every 6 months. This included all subjects and data records irrespective of failed eligibility criteria, receipt of prohibited medications, discontinued treatment for any reason, had errors or deviations in dosing, or receipt of both doses. Bone density measurement were performed by DXA. All DXA scans were submitted to a central imaging vendor for analysis.

    Time frame: Baseline (screening), Month 6, Month 12.

  4. 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)

    Geometric meant (geometric CV%) sCTX Area under the effect curve from zero to 6 months (AUEC0-6 months) after first dose in postmenopausal women with osteoporosis treated with SC denosumab injections every 6 months assuming all women received their first denosumab dose without any errors in dosing and without receipt of any prohibited therapies or other osteoporosis medications up to 6 months after first dose.

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

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

    AUIC0-6 months = Area under the inhibition curve for % change from baseline sCTX concentrations from time zero to 6 months

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

  6. Pharmacokinetics: Maximum Observed Serum Concentration (Cmax) of Denosumab After First Dose Study Treatment (Pharmacokinetic Parameter Analysis Set)

    To assess the PK profile of MB09 compared with EU-Prolia following the first dose, maximum Observed Serum Concentration (Cmax) of Denosumab After First Dose study treatment (Pharmacokinetic Parameter Analysis Set).

    Time frame: Baseline (pre-dose Day 1), up to Month 6

  7. Pharmacokinetics: To Assess the PK Profile of MB09 Compared With EU Prolia (AUC0-6 Months) Following the First Dose

    Area under the concentration-time curve from time zero to 6 months analysed on the log scale by ANCOVA. The model will include treatment and stratification variables (baseline BMD T-score at the lumbar spine (≤ -3.0 and \> -3.0 SD), body mass index (\< 25 and ≥ 25 kg/m2), age at study entry (≥ 55 to \< 68 years versus ≥ 68 to ≤ 80 years) and prior bisphosphonate medication use at study entry (prior use of bisphosphonates versus no prior bisphosphonate use as fixed effects. The estimated mean difference with 95% CI will be back-transformed to give the ratio of geometric means (MB09/EU-Prolia) with 95% CI following the first dose in the Main Treatment Period.

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

  8. Safety: Overall Summary of Adverse Events - Main Treatment Period - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)

    For Main Treatment Period, treatment-emergent adverse event (TEAE) was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.

    Time frame: From first administration of study treatment on Day 1 until Month 18

  9. Safety: New Clinical Bone Fractures - TEAEs (Throughout the Study - From Day 1 Untill Month 18)

    For the Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.

    Time frame: All participants in the Main Treatment Period and Transition Period (From Day 1 untill Month 18)

  10. Overall Incidence of Antidrug Antibodies (ADA) - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)

    Number of subjects experiencing treatment-induced immunogenicity: Binding and neutralising serum denosumab antibodies from baseline up to and including Month 18. Analysis of immunogenicity data will be based on ADA evaluable subjects defined as all SAF or SAF-TP subjects with baseline and at least one post-baseline immunogenicity assessment within the Main Treatment Period or the Transition Period. The formation of ADAs against MB09 or EU-Prolia was assessed in blood samples.

    Time frame: From baseline (pre-dose) up to and including Month 18.

07

Results

Posted Mar 21, 2025

Participant flow

A total of 62 sites in 8 countries (Bulgaria, Estonia, Georgia, Hungary, Latvia, Poland, Serbia, and Mexico) screened at least one subject and 56 sites randomised at least one subject into the study.

Main Treatment Period (Day1 to Month 12)
Participant flow — Main Treatment Period (Day1 to Month 12)
MilestoneMB09 (MTP)EU-Prolia (MTP)MB09-MB09 (TP)EU-Prolia-MB09 (TP)EU Prolia-EU Prolia (TP)
Started281277000
Safety analysis set (saf)277278000
Full analysis set (fas)278277000
Modified full analysis set (mfas)258266000
Pharmacokinetics parameter set (pkps)269274000
Pharmacokinetics concentration set (pkcs)277278000
Completed245252000
Not completed3625000
Withdrew: Adverse event40000
Withdrew: Lost to follow-up12000
Withdrew: Protocol violation11000
Withdrew: Unrelated medical conditions10000
Withdrew: Subject dosed in error and did not meet eligibility criteria66000
Withdrew: Other2316000
Transition Period (M12 to M18)
Participant flow — Transition Period (M12 to M18)
MilestoneMB09 (MTP)EU-Prolia (MTP)MB09-MB09 (TP)EU-Prolia-MB09 (TP)EU Prolia-EU Prolia (TP)
Started00245130122
Safety analysis set for transition period (saf-tp).00244130123
Full analysis set for transition period (fas-tp)00245130122
Modified full analysis set for transition period (mfas-tp)00233127121
Pharmacokinetic concentration set for transition period (pkcs-tp)00244130123
Pharmacokinetic parameter set for transition period (pkps-tp)00228126111
Completed00239127119
Not completed00633
Withdrew: Death00100
Withdrew: Withdrawal by subject00432
Withdrew: Burden of study procedures00100
Withdrew: Subject left the country00001

Outcome measures

PrimaryEfficacy: 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.

Time frame:
Baseline (Screening), up to Week 52
Reported as:
Least squares mean · Percentage change (%)
Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (LS-BMD) at 52 Weeks - Modified Full Analysis Set (mFAS)
Percentage change (%)MB09EU-Prolia
Efficacy: Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (LS-BMD) at 52 Weeks - Modified Full Analysis Set (mFAS)5.86 ± 0.265.66 ± 0.25
Statistical analysis
  • MB09 vs EU-Prolia · Mixed Models Analysis · Mean difference (final values): 0.20 · 95% CI -0.51 to 0.91MMRM included treatment, with stratification variables as classification factors and baseline BMD as a continuous covariate.
SecondaryEfficacy: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52 - Full Analysis Set (FAS)

Difference in means (MB09-Prolia) in the %CfB in lumbar spine BMD after 12 months in postmenopausal women with osteoporosis treated with SC denosumab injections every 6 months. This included all subjects and data records irrespective of failed eligibility criteria, receipt of prohibited medications, discontinued treatment for any reason, had errors or deviations in dosing, or receipt of both doses. Estimation was via Multiple Imputation (MI) and ANCOVA on the FAS. Since the retrieved dropout rate was low, a treatment-failure (TF) penalty was applied to the imputed values at Month 12 for those subjects who received only one dose of the study treatment to centre the distribution of each subject's %CfB values around their baseline level. Bone density measurements were performed by DXA. All DXA scans were submitted to a central imaging vendor for analysis.

Time frame:
Baseline (screening), up to Week 52
Reported as:
Least squares mean · Percentage change (%)
Efficacy: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52 - Full Analysis Set (FAS)
Percentage change (%)MB09EU-Prolia
Efficacy: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52 - Full Analysis Set (FAS)5.40 ± 0.265.38 ± 0.26
Statistical analysis
  • MB09 vs EU-Prolia · ANCOVA · Mean difference (final values): 0.03 · 95% CI -0.69 to 0.74The estimated mean difference in %CfB lumbar spine BMD results was pooled using Rubin's methods and presented with 95% CI.
SecondaryEfficacy: 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

To assess the efficacy of MB09 to EU-Prolia in postmenopausal women with osteoporosis in terms of Lumbar Spine at Month 6 and Total Hip and Femur Neck BMD at Month 6 and Month12. The difference in means in %CfB in lumbar spine BMD between MB09 and Prolia at Month 6 and Total Hip and Femur Neck at Month 6 and Month 12 from an MMRM presented for the mFAS. Bone density measurements were performed by DXA. All DXA scans were submitted to a central imaging vendor for analysis.

Time frame:
Baseline (screening), Month 6 and Month 12.
Reported as:
Least squares mean · percentage change (%)
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
percentage change (%)MB09EU-Prolia
Total Hip - Month 123.37 ± 0.183.28 ± 0.17
Femur Neck - Month 122.75 ± 0.232.39 ± 0.23
Lumbar Spine - Month 64.03 ± 0.233.96 ± 0.22
Total Hip - Month 62.29 ± 0.162.46 ± 0.16
Femur Neck - Month 62.18 ± 0.221.93 ± 0.21
SecondaryEfficacy: 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

To assess the efficacy of MB09 to EU-Prolia in postmenopausal women with osteoporosis in terms of the difference in means (MB09-Prolia) in the %CfB in Lumbar Spine BMD at Month 6 and Total Hip and Femur Neck BMD at Month 6 and 12 in postmenopausal women with osteoporosis treated with SC denosumab injections every 6 months. This included all subjects and data records irrespective of failed eligibility criteria, receipt of prohibited medications, discontinued treatment for any reason, had errors or deviations in dosing, or receipt of both doses. Bone density measurement were performed by DXA. All DXA scans were submitted to a central imaging vendor for analysis.

Time frame:
Baseline (screening), Month 6, Month 12.
Reported as:
Least squares mean · percentage change (%)
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
percentage change (%)MB09EU-Prolia
Total Hip - Month 123.31 ± 0.173.27 ± 0.17
Femur Neck- Month 122.70 ± 0.232.38 ± 0.22
Lumbar Spine - Month 63.82 ± 0.223.92 ± 0.22
Total Hip - Month 62.28 ± 0.162.49 ± 0.16
Femur Neck - Month 62.18 ± 0.211.92 ± 0.21
SecondaryPharmacodynamics: 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)

Geometric meant (geometric CV%) sCTX Area under the effect curve from zero to 6 months (AUEC0-6 months) after first dose in postmenopausal women with osteoporosis treated with SC denosumab injections every 6 months assuming all women received their first denosumab dose without any errors in dosing and without receipt of any prohibited therapies or other osteoporosis medications up to 6 months after first dose.

Time frame:
Baseline (pre-dose Day 1), up to Month 6.
Reported as:
Geometric mean · day*pg/mL
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)
day*pg/mLMB09EU-Prolia
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 ± 49.712400 ± 44.1
Statistical analysis
  • MB09 vs EU-Prolia · ANCOVA · Ratio of geometric means: 99.91 · 95% CI 91.99 to 108.52ANCOVA model including log-transformed baseline sCTX as a continuous covariate with treatment and stratification variables as fixed effects.
SecondaryPharmacodynamics: %CfB Area Under the Percent Inhibition Curve From Time Zero to 6 Months (AUIC0-6 Months) in sCTX - on mFAS

AUIC0-6 months = Area under the inhibition curve for % change from baseline sCTX concentrations from time zero to 6 months

Time frame:
Baseline (pre-dose Day 1), up to Month 6.
Reported as:
Geometric mean · day* %
Pharmacodynamics: %CfB Area Under the Percent Inhibition Curve From Time Zero to 6 Months (AUIC0-6 Months) in sCTX - on mFAS
day* %MB09EU-Prolia
Pharmacodynamics: %CfB Area Under the Percent Inhibition Curve From Time Zero to 6 Months (AUIC0-6 Months) in sCTX - on mFAS15100 ± 17.415300 ± 13.6
Statistical analysis
  • MB09 vs EU-Prolia · ANCOVA · Ratio of geometric means: 99.13 · 95% CI 96.31 to 102.02
SecondaryPharmacokinetics: Maximum Observed Serum Concentration (Cmax) of Denosumab After First Dose Study Treatment (Pharmacokinetic Parameter Analysis Set)

To assess the PK profile of MB09 compared with EU-Prolia following the first dose, maximum Observed Serum Concentration (Cmax) of Denosumab After First Dose study treatment (Pharmacokinetic Parameter Analysis Set).

Time frame:
Baseline (pre-dose Day 1), up to Month 6
Reported as:
Geometric mean · ng/mL
Pharmacokinetics: Maximum Observed Serum Concentration (Cmax) of Denosumab After First Dose Study Treatment (Pharmacokinetic Parameter Analysis Set)
ng/mLMB09EU-Prolia
Pharmacokinetics: Maximum Observed Serum Concentration (Cmax) of Denosumab After First Dose Study Treatment (Pharmacokinetic Parameter Analysis Set)5960 ± 31.15700 ± 35.9
Statistical analysis
  • MB09 vs EU-Prolia · ANCOVA · Ls geometric mean ratio: 104.13 · 95% CI 98.83 to 109.71Cmax was analysed on the log scale by ANCOVA. The model included treatment and stratification variables as fixed effects.
SecondaryPharmacokinetics: To Assess the PK Profile of MB09 Compared With EU Prolia (AUC0-6 Months) Following the First Dose

Area under the concentration-time curve from time zero to 6 months analysed on the log scale by ANCOVA. The model will include treatment and stratification variables (baseline BMD T-score at the lumbar spine (≤ -3.0 and \> -3.0 SD), body mass index (\< 25 and ≥ 25 kg/m2), age at study entry (≥ 55 to \< 68 years versus ≥ 68 to ≤ 80 years) and prior bisphosphonate medication use at study entry (prior use of bisphosphonates versus no prior bisphosphonate use as fixed effects. The estimated mean difference with 95% CI will be back-transformed to give the ratio of geometric means (MB09/EU-Prolia) with 95% CI following the first dose in the Main Treatment Period.

Time frame:
Baseline (pre-dose Day 1), up to Month 6.
Reported as:
Geometric mean · day*ng/mL
Pharmacokinetics: To Assess the PK Profile of MB09 Compared With EU Prolia (AUC0-6 Months) Following the First Dose
day*ng/mLMB09EU-Prolia
Pharmacokinetics: To Assess the PK Profile of MB09 Compared With EU Prolia (AUC0-6 Months) Following the First Dose360,000 ± 36.5337000 ± 39.5
Statistical analysis
  • MB09 vs EU-Prolia · ANCOVA · Ls geometric mean ratio: 106.06 · 95% CI 99.84 to 112.66AUC0-6 months was analysed on the log scale by ANCOVA. The model included treatment and stratification variables as fixed effects.
SecondarySafety: Overall Summary of Adverse Events - Main Treatment Period - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)

For Main Treatment Period, treatment-emergent adverse event (TEAE) was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.

Time frame:
From first administration of study treatment on Day 1 until Month 18
Reported as:
Count of participants · Participants
Safety: Overall Summary of Adverse Events - Main Treatment Period - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)
ParticipantsMain Treatment Period: MB09Main Treatment Period: EU-ProliaThroughout the Study: MB09-MB09Throughout the Study: Prolia-MB09Throughout the Study: Prolia-Prolia
Any TEAEs1611501808775
Any study treatment-related TEAEs4124451117
Any serious TEAEs191321114
Any study treatment-related serious TEAEs11101
SecondarySafety: New Clinical Bone Fractures - TEAEs (Throughout the Study - From Day 1 Untill Month 18)

For the Main Treatment Period, TEAE was an event observed after first dose on Day 1 until Month 12 and no more than 6 months after the last dose in case of early treatment discontinuation unless the TEAE was considered as related to the study treatment by investigator. For Transition Period, TEAE was an event observed after the third dose of study treatment at Month 12 until Month 18. Throughout the study, TEAE was an event observed after first dose on Day 1 until Month 18.

Time frame:
All participants in the Main Treatment Period and Transition Period (From Day 1 untill Month 18)
Reported as:
Count of participants · Participants
Safety: New Clinical Bone Fractures - TEAEs (Throughout the Study - From Day 1 Untill Month 18)
ParticipantsThroughout the Study: MB09-MB09Throughout the Study: EU Prolia-MB09Throughout the Study: EU Prolia- EU Prolia
Number of subjects with at least one fracture TEAE (any bone)1264
Number of subjects with at least one Vertebral fracture321
Number of subjects with at least one Hip fracture110
Number of subjects with at least one Pelvic fracture100
SecondaryOverall Incidence of Antidrug Antibodies (ADA) - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)

Number of subjects experiencing treatment-induced immunogenicity: Binding and neutralising serum denosumab antibodies from baseline up to and including Month 18. Analysis of immunogenicity data will be based on ADA evaluable subjects defined as all SAF or SAF-TP subjects with baseline and at least one post-baseline immunogenicity assessment within the Main Treatment Period or the Transition Period. The formation of ADAs against MB09 or EU-Prolia was assessed in blood samples.

Time frame:
From baseline (pre-dose) up to and including Month 18.
Reported as:
Count of participants · Participants
Overall Incidence of Antidrug Antibodies (ADA) - Safety Analysis Set (SAF) and Safety Analysis Set for Transition Period (SAF-TP)
ParticipantsThroughout the Study: MB09-MB09Throughout the Study: EU Prolia-MB09Throughout the Study: EU Prolia- EU Prolia
ADA positive133
NAb positive000

Adverse events

Collected over Subject incidence of TEAEs up to and including Month 18.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Main Treatment Period: MB090/277 (0%)19/277 (6.9%)120/277 (43.3%)
Main Treatment Period: EU-Prolia0/278 (0%)13/278 (4.7%)120/278 (43.2%)
Throughout the Study: MB09-MB091/277 (0.4%)21/277 (7.6%)180/277 (65%)
Throughout the Study: EU Prolia-MB090/140 (0%)11/140 (7.9%)87/140 (62.1%)
Throughout the Study: EU Prolia-EU Prolia0/138 (0%)4/138 (2.9%)75/138 (54.3%)
Most frequent serious events
Showing 10 of 41
Most frequent serious events
EventMain Treatment Period: MB09Main Treatment Period: EU-ProliaThroughout the Study: MB09-MB09Throughout the Study: EU Prolia-MB09Throughout the Study: EU Prolia-EU Prolia
Cardiac disorderCardiac disorders0/2770/2780/2770/1401/138
DiverticulitisInfections and infestations0/2770/2780/2770/1401/138
Post-acute COVID-19 syndromeInfections and infestations0/2771/2780/2770/1401/138
SteatohepatitisHepatobiliary disorders0/2771/2780/2770/1401/138
MigraineNervous system disorders0/2771/2780/2770/1401/138
ThrombophlebitisVascular disorders0/2770/2780/2770/1401/138
PneumoniaInfections and infestations1/2770/2782/2770/1400/138
Bundle branch block leftCardiac disorders0/2771/2780/2771/1400/138
Gastric polypsGastrointestinal disorders0/2771/2780/2771/1400/138
Pancreatitis acuteGastrointestinal disorders0/2771/2780/2771/1400/138
Most frequent other events
Showing 10 of 25
Most frequent other events
EventMain Treatment Period: MB09Main Treatment Period: EU-ProliaThroughout the Study: MB09-MB09Throughout the Study: EU Prolia-MB09Throughout the Study: EU Prolia-EU Prolia
NasopharyngitisInfections and infestations10/27723/27815/27715/14011/138
Upper respiratory tract infectionInfections and infestations20/27720/27825/27713/14012/138
COVID-19Infections and infestations14/27715/27821/27711/14010/138
ArthralgiaMusculoskeletal and connective tissue disorders15/27715/27817/2775/14010/138
Urinary tract infectionInfections and infestations9/2779/27818/2778/1402/138
OsteoarthritisMusculoskeletal and connective tissue disorders9/27710/27811/2774/1407/138
HypertensionVascular disorders10/2776/27810/2774/1406/138
Blood parathyroid hormone increasedInvestigations11/2774/27811/2772/1402/138
Back painMusculoskeletal and connective tissue disorders6/2777/2787/2775/1403/138
HypercholesterolaemiaMetabolism and nutrition disorders0/2770/2787/2775/1401/138

Baseline characteristics

The Safety Analysis Set (SAF) consisted of all randomised subjects who received at least one administration of study treatment.

Age, Continuous
Age, Continuous(years)MB09EU-ProliaTotal
Mean65.8 ± 6.0065.9 ± 5.9065.8 ± 5.94
Sex: Female, Male
Sex: Female, Male(Participants)MB09EU-ProliaTotal
Female277278555
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)MB09EU-ProliaTotal
Race - White276275551
Race - American Indian or Alaska Native134
Ethnicity - Hispanic or Latino101323
Ethnicity - Not Hispanic or Latino267265532
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)MB09EU-ProliaTotal
Mean24.62 ± 3.0124.73 ± 3.0624.68 ± 3.04
Osteoporosis diagnosis duration
Osteoporosis diagnosis duration(years)MB09EU-ProliaTotal
Mean2.6 ± 4.392.0 ± 3.892.3 ± 4.15
Baseline BMD T-score at the lumbar spine
Baseline BMD T-score at the lumbar spine(Participants)MB09EU-ProliaTotal
> -3.0 group144143287
≤ -3.0 group133135268
Lumbar spine BMD
Lumbar spine BMD(g/cm^2)MB09EU-ProliaTotal
Mean0.766 ± 0.08780.773 ± 0.08620.770 ± 0.0870
Total hip BMD
Total hip BMD(g/cm^2)MB09EU-ProliaTotal
Mean0.731 ± 0.09730.745 ± 0.09460.738 ± 0.0961

4 further baseline measures are reported on the registry.

08

Study locations

64 sites
  • 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, Harjumaa, Estonia
  • East Tallinn Central Hospital
    Tallinn, Harjumaa, Estonia
  • North Estonia Medical Centre Foundation
    Tallinn, Harjumaa, Estonia
  • KLV Arstikabinet
    Pärnu, Pärnu Maakon, Estonia
  • Clinical Research Centre Ltd
    Tartu, Tartumaa, Estonia
  • MediTrials OÜ
    Tartu, Tartumaa, Estonia
  • Tartu University Hospital
    Tartu, Tartumaa, 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, Békés, Hungary
  • AES - DRS - Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft
    Gyula, Békés, Hungary
  • Csongrad Megyei Dr. Bugyi Istvan Korhaz
    Szentes, Csongrád, 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, Hungary
  • AES - DRS - Synexus Zalaegerszeg Magyarország Egészségügyi Kft
    Zalaegerszeg, Zala, 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
  • Hospital Angeles Lindavista (Consultorio de Reumatologia)
    Ciudad de Mexico, Distrito Federal, Mexico
  • Centro de Estudios de Investigacion Basica Y Clinica SC
    Guadalajara, Jalisco, 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, Mexico
  • Globe Badania Kliniczne Spólka z o.o.
    Kłodzko, Dolnoslaskie, Poland
  • Lubelskie Centrum Diagnostyczne (Lotników Polskich)
    Świdnik, Lubelskie, Poland
  • Lubelskie Centrum Diagnostyczne
    Świdnik, Lubelskie, Poland
  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
    Warszawa, Mazowieckie, Poland
  • Bialystok - ClinicMed Daniluk, Nowak Spólka Jawna
    Bialystok, Podlaskie, Poland
  • NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik
    Bialystok, Podlaskie, Poland
  • Centrum Medyczne Czestochowa - PRATIA - PPDS
    Częstochowa, Slaskie, Poland
  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
    Poznań, Wielkopolskie, Poland
  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
    Bydgoszcz, Poland
  • Centrum Medyczne Katowice - PRATIA - PPDS
    Katowice, Poland
  • Krakowskie Centrum Medyczne
    Krakow, Poland
  • Centrum Medyczne Linden
    Kraków, Poland
  • MCM Krakow - PRATIA - PPDS
    Kraków, 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
    Wrocław, Poland
  • Institute of Rheumatology Belgrade - PPDS
    Belgrad, Serbia
  • Military Medical Academy
    Belgrad, Serbia
  • University Clinical Center of Serbia - PPDS
    Belgrad, Serbia
  • Clinical Centre of Vojvodina
    Novi Sad, Serbia
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05338086
Lead sponsor
mAbxience Research S.L.
Responsible party
Sponsor
First posted
Apr 20, 2022
Start date
Mar 16, 2022
Primary completion
Dec 14, 2023
Completion
May 22, 2024
Results posted
Mar 21, 2025
Last update
Mar 21, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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