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

> **NCT05338086** · PHASE3 · COMPLETED · sponsor: **mAbxience Research S.L.** · enrollment: 558 (actual)

## Conditions studied

- Postmenopausal Women With Osteoporosis

## Interventions

- **DRUG:** MB09 (denosumab biosimilar)
- **DRUG:** EU-Prolia
- **DIETARY_SUPPLEMENT:** Elemental Calcium
- **DIETARY_SUPPLEMENT:** Vitamin D

## Key facts

- **NCT ID:** NCT05338086
- **Lead sponsor:** mAbxience Research S.L.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-03-16
- **Primary completion:** 2023-12-14
- **Final completion:** 2024-05-22
- **Target enrollment:** 558 (ACTUAL)
- **Last updated:** 2025-03-21


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05338086

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05338086, "A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT05338086. Licensed CC0.

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