# Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

> **NCT03974100** · PHASE3 · COMPLETED · sponsor: **Sandoz** · enrollment: 527 (actual)

## Conditions studied

- Postmenopausal Women With Osteoporosis

## Interventions

- **BIOLOGICAL:** GP2411
- **BIOLOGICAL:** EU-Prolia (EU-authorized Prolia®)

## Key facts

- **NCT ID:** NCT03974100
- **Lead sponsor:** Sandoz
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-07-02
- **Primary completion:** 2022-04-22
- **Final completion:** 2022-04-22
- **Target enrollment:** 527 (ACTUAL)
- **Last updated:** 2023-03-08

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03974100

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03974100, "Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT03974100. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*