NCT04729621

A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis

A Randomized, Double-Blind, Multinational, Multicenter Study to Compare Efficacy, Safety, and Immunogenicity of TVB-009P and Denosumab (Prolia®) in Patients With Postmenopausal Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Female
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)

Detailed description

This is a multinational, multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of TVB-009 compared to Prolia® administered subcutaneously at doses of 60 mg every 26 weeks. Approximately 326 postmenopausal women with osteoporosis will be randomized to receive either TVB-009 or Prolia®. At week 52, patients in the Prolia® arm will be re-randomized 1:1 to either continue with a third dose of Prolia® or transition to TVB-009 and receive a single dose of TVB-009 in the transition period to assess immunogenicity and safety after a transition from Prolia® to TVB-009. The total treatment duration for each patient is 78 weeks.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
COMBINATION_PRODUCT	TVB-009	TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
COMBINATION_PRODUCT	Prolia®	Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Timeline

• Start date: 2021-03-22
• Primary completion: 2022-12-31
• Completion: 2023-06-19
• First posted: 2021-01-28
• Last updated: 2024-04-18
• Results posted: 2024-04-18

Locations

78 sites across 10 countries: United States, Bulgaria, Czechia, Georgia, Germany, Hungary, Poland, Russia, Slovakia, Ukraine

Regulatory

• FDA-regulated drug study