Clinical Trials Logo
  1. Home
  2. Osteoporosis, Postmenopausal
  3. NCT04729621

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

Osteoporosis, Postmenopausal Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04729621
Study type Interventional
Source Teva Pharmaceuticals USA
Contact
Status Completed
Phase Phase 3
Start date March 22, 2021
Completion date June 19, 2023
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03931109 - Circulating miRNA in Primary Hyperparathyroidism
Not yet recruiting NCT03232476 - Effect of Mechanical Loading With PTH on Cortical Bone Phase 4
Completed NCT02884401 - Peri-implant Bone Changes in Post-menopausal Osteoporotic Women N/A
Completed NCT00073190 - Patient- and Physician-Based Osteoporosis Education Phase 1
Completed NCT00402441 - Risedronate in the Prevention of Osteoporosis in Postmenopausal Women Phase 4
Completed NCT03710889 - Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption Phase 3
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Recruiting NCT05058976 - Romosozumab Use to Build Skeletal Integrity Phase 4
Active, not recruiting NCT05405894 - Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
Recruiting NCT03337971 - Nutritional Supplement and Bone Health in Post-Menopausal Women N/A
Completed NCT03701113 - Milk Protein and Bone Health in Postmenopausal Women N/A
Completed NCT01381588 - The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women N/A
Completed NCT00383422 - Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis Phase 3
Completed NCT00549965 - Satisfaction and Compliance of Risedronate in PMO Phase 4
Completed NCT00035256 - Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis Phase 4
Completed NCT01386281 - Julina Post-marketing Surveillance for Climacteric Symptoms in Japan
Completed NCT05266261 - Use of Ibandronate in Diabetic Patients N/A
Recruiting NCT04964388 - Effect of GLP-1 Receptor Agonists on Trabecular Bone Score Phase 2
Active, not recruiting NCT03623633 - Comparative Antiresorptive Efficacy Discontinuation of Denosumab Phase 4
Recruiting NCT05575167 - Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)