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A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

NCT04664959 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 457

Last updated 2025-02-04

Study results available
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Summary

This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

SB16 (Proposed Denosumab Biosimilar)

Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months. At Month 12, subjects transited from Prolia® group to SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously.

DRUG

Prolia® (Denosumab)

Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months.

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-26
Primary Completion
2022-06-20
Completion
2023-01-03

Countries

  • Poland

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 NCT04664959 on ClinicalTrials.gov