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

NCT04729621 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2024-04-18

Study results available
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Summary

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

Conditions

  • Osteoporosis, Postmenopausal

Interventions

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)

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    collaborator INDUSTRY

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2022-12-31
Completion
2023-06-19
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Georgia
  • Germany
  • Hungary
  • Poland
  • Russia
  • Slovakia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04729621 on ClinicalTrials.gov