Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

PHASE3CompletedINTERVENTIONAL
Enrollment

527

Participants

Timeline

Start Date

July 2, 2019

Primary Completion Date

April 22, 2022

Study Completion Date

April 22, 2022

Conditions
Postmenopausal Women With Osteoporosis
Interventions
BIOLOGICAL

GP2411

60 mg /mL subcutaneous injection every 6 months

BIOLOGICAL

EU-Prolia (EU-authorized Prolia®)

60 mg /mL subcutaneous injection every 6 months

Trial Locations (42)

1431

Sandoz Investigational Site, Sofia

1505

Sandoz Investigational Site, Sofia

1680

Sandoz Investigational Site, Sofia

1784

Sandoz Investigational Site, Sofia

4001

Sandoz Investigational Site, Plovdiv

4002

Sandoz Investigational Site, Plovdiv

14900

Sandoz Investigational Site, Prague

15705

Sandoz Investigational Site, Santiago de Compostela

15706

Sandoz Investigational Site, Santiago de Compostela

16635

Sandoz Investigational Site, Duncansville

19610

Sandoz Investigational Site, Wyomissing

28009

Sandoz Investigational Site, Madrid

30460

Sandoz Investigational Site, Pilsen

33135

Sandoz Investigational Site, Miami

41010

Sandoz Investigational Site, Seville

67207

Sandoz Investigational Site, Wichita

75010

Sandoz Investigational Site, Carrollton

85381

Sandoz Investigational Site, Peoria

772 00

Sandoz Investigational Site, Ostrava

500 05

Sandoz Investigational Site, Hradec Králové

602 00

Sandoz Investigational Site, Brno

702 00

Sandoz Investigational Site, Ostrava

530 02

Sandoz Investigational Site, Pardubice

128 50

Sandoz Investigational Site, Prague

686 01

Sandoz Investigational Site, Uherské Hradiště

354-0021

Sandoz Investigational Site, Fujimi

104-0031

Sandoz Investigational Site, Chuoh-ku

192-0046

Sandoz Investigational Site, Hachiōji

204-0021

Sandoz Investigational Site, Kiyose

140-0014

Sandoz Investigational Site, Shinagawa

30-510

Sandoz Investigational Site, Krakow

15-351

Sandoz Investigational Site, Bialystok

15-461

Sandoz Investigational Site, Bialystok

85 168

Sandoz Investigational Site, Bydgoszcz

90 242

Sandoz Investigational Site, Lodz

05-830

Sandoz Investigational Site, Nadarzyn

87-100

Sandoz Investigational Site, Torun

00-874

Sandoz Investigational Site, Warsaw

02 118

Sandoz Investigational Site, Warsaw

02 691

Sandoz Investigational Site, Warsaw

08208

Sandoz Investigational Site, Sabadell

08041

Sandoz Investigational Site, Barcelona

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Hexal AG

INDUSTRY

lead

Sandoz

INDUSTRY