Clinical trial

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

NCT04729621

Name

TVB009-IMB-30085

Description

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

Trial arms

Trial start

2021-03-22

Estimated PCD

2022-12-31

Trial end

2023-06-19

Status

Completed

Phase

Early phase I

Treatment

TVB-009

TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Arms:

PROLIA main / TVB-009 transition period, TVB-009 main / TVB-009 transition period, TVB-009 main treatment period

Prolia®

Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Arms:

PROLIA main / PROLIA transition period, PROLIA main / TVB-009 transition period, PROLIA main treatment period

Size

332

Primary endpoint

Percent Change From Baseline in LS-BMD at Week 52

Baseline and week 52

Eligibility criteria

Inclusion Criteria: * Postmenopausal womeen (≥60 and ≤90 years) with a diagnosis of osteoporosis * Body weight ≥50 kg and ≤90 kg * Bone Mineral Density (BMD) measurement T score of less than -2.5 but not less than -4.0 by dual-energy X-ray absorptiometry (DXA) at the lumbar spine at screening * At least 3 vertebrae in the L1 L4 region that are evaluable by dual-energy X-ray absorptiometry (DXA) Exclusion Criteria: * One severe or more than two moderate vertebral fractures * History and/or presence of hip fracture or atypical femur fracture * Any prior treatment with denosumab * Ongoing use of any bone active drugs which can affect Bone Mineral Density (BMD) * Vitamin D deficiency or hyper- or hypocalcemiacium at screening * Hyperthyroidism, hypothyroidism, hypoparathyroidism or hyperparathyroidism * Any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study Other Inclusion/exclusion criteria may apply

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 332, 'type': 'ACTUAL'}}

Updated at

2024-04-18

1 organization

2 products

2 indications

Product

Indication

Indication

Organization

Product