At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 332 enrolled
Drug / intervention
TVB-009 +1 morecombination
Likely dose
TVB-009 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Multinational, Multicenter Study to Compare Efficacy, Safety, and Immunogenicity of TVB-009P and Denosumab (Prolia®) in Patients With Postmenopausal Osteoporosis
In Brief
A Phase 3 clinical trial evaluating TVB-009 and Prolia® for Osteoporosis, Postmenopausal. Completed, enrolled 332 participants across 78 sites in 10 countries.
Detailed Summary
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Postmenopausal
CountriesBulgaria, Czechia, Georgia, Germany, Hungary, Poland, Russia, Slovakia, Ukraine, United States
CollaboratorsTeva Branded Pharmaceutical Products R&D, Inc.
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJan 2021
Enrollment StartMar 2021
Primary CompletionDec 2022
Study CompletionJun 2023
TodayJul 2026
First PostedJan 28, 2021
Enrollment StartMar 22, 2021
Primary CompletionDec 31, 2022
Study CompletionJun 19, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.4 years ago
Interventions
TVB-009combination
TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®combination
Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)