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Monoclonal Antibodies

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

Phase 3
Waitlist Available
Research Sponsored by Sandoz
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-dose day 1), day 4, week 1, week 2, week 8, week 14, week 18, week 22, week 26, week 39 and week 52
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares a new bone-strengthening drug called GP2411 with an existing drug called Prolia® in women with weak bones after menopause. The study aims to see if the new drug works just as well as the original. Both drugs help keep bones strong by stopping the cells that break down bone tissue.

Eligible Conditions
  • Osteoporosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-dose day 1), day 4, week 1, week 2, week 8, week 14, week 18, week 22, week 26, week 39 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-dose day 1), day 4, week 1, week 2, week 8, week 14, week 18, week 22, week 26, week 39 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Effect-time Curve (AUEC) of Percentage Change From Baseline in Serum CTX Concentrations After First Dose - Pharmacodynamic Analysis Set
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) of Denosumab After First Dose
Maximum Observed Serum Concentration (Cmax) of Denosumab After First Dose
+2 more
Secondary study objectives
CTX Serum Concentrations as Per Visit Schedule From Week 52 up to Week 78 - Treatment Period 2
CTX Serum Concentrations as Per Visit Schedule up to Week 52 - Treatment Period 1
Denosumab Serum Concentrations as Per Visit Schedule From Week 52 up to Week 78 - Treatment Period 2
+22 more

Side effects data

From 2022 Phase 3 trial • 527 Patients • NCT03974100
10%
Hypocalcaemia
6%
Nasopharyngitis
5%
Headache
5%
COVID-19
5%
Vitamin D deficiency
4%
Injection site reaction
4%
Urinary tract infection
3%
Diarrhoea
3%
Cystitis
3%
Upper respiratory tract infection
3%
Arthralgia
3%
Back pain
3%
Spinal osteoarthritis
2%
Contusion
2%
Spinal compression fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
EU-Prolia
EU-Prolia/EU-Prolia
EU-Prolia/GP2411
GP2411
GP2411/GP2411

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GP2411Experimental Treatment1 Intervention
60 mg /mL subcutaneous injection every 6 months
Group II: EU authorized ProliaActive Control1 Intervention
60 mg /mL subcutaneous injection every 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GP2411
2019
Completed Phase 3
~530

Find a Location

Who is running the clinical trial?

Hexal AGIndustry Sponsor
9 Previous Clinical Trials
6,074 Total Patients Enrolled
SandozLead Sponsor
143 Previous Clinical Trials
25,748 Total Patients Enrolled
~82 spots leftby Dec 2025
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