NCT04664959View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

457

Participants

Timeline

Start Date

November 26, 2020

Primary Completion Date

June 20, 2022

Study Completion Date

January 3, 2023

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.

Trial Locations (5)

Unknown

SB Investigative Site, Krakow

SB Investigative Site, Lodz

SB Investigative Site, Siedlce

SB Investigative Site, Warsaw

SB Investigative Site, Zamość

All Listed Sponsors
lead

Samsung Bioepis Co., Ltd.

INDUSTRY

NCT04664959 - A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis | Biotech Hunter | Biotech Hunter