NCT05395091View on ClinicalTrials.gov

Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

PHASE3CompletedINTERVENTIONAL
Enrollment

532

Participants

Timeline

Start Date

August 23, 2022

Primary Completion Date

May 7, 2024

Study Completion Date

October 28, 2024

Conditions
Osteoporosis, Postmenopausal
Interventions
BIOLOGICAL

AVT03

AVT03 (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL to be administered as a subcutaneous injection. Subjects in this arm received AVT03 60mg administered s.c. on Day 1 and at Month 6. At Month 12, subjects in the AVT03 arm received a third dose of AVT03 60 mg.

BIOLOGICAL

Denosumab

"Prolia (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL developed to be administered as a subcutaneous injection.~Subjects in this arm received 60mg of commercially available US-Prolia, administered s.c on Day 1 and at Month 6. At Month 12, subjects in the Prolia treatment group were re-randomized in a 1:1 ratio to receive either:~* AVT03 60 mg administered s.c. on Day365.~* Prolia 60 mg administered s.c. on Day365."

Trial Locations (34)

Unknown

Investigational Site 3501, Plovdiv

Investigational Site 3503, Plovdiv

Investigational Site 3502, Stara Zagora

Investigational Site 4201, Prague

Investigational Site 4202, Uherské Hradiště

Investigational Site 9901, Tbilisi

Investigational Site 9902, Tbilisi

Investigational Site 9903, Tbilisi

Investigational Site 9904, Tbilisi

Investigational Site 9905, Tbilisi

Investigational Site 9906, Tbilisi

Investigational Site 4803, Bialystok

Investigational Site 4804, Bialystok

Investigational Site 4802, Krakow

Investigational Site 4807, Krakow

Investigational Site 4806, Lodz

Investigational Site 4811, Lublin

Investigational Site 4812, Poznan

Investigational Site 4801, Skierniewice

Investigational Site 4805, Świdnik

Investigational Site 4809, Warsaw

Investigational Site 4810, Zamość

Investigational Site 2705, Bloemfontein

Investigational Site 2714, Cape Town

Investigational Site 2707, Centurion

Investigational Site 2708, Centurion

Investigational Site 2710, Groenkloof

Investigational Site 2712, Johannesburg

Investigational Site 2702, KwaDukuza

Investigational Site 2711, Parow

Investigational Site 2701, Port Elizabeth

Investigational Site 2706, Pretoria

Investigational Site 2713, Pretoria

Investigational Site 2703, Worcester

All Listed Sponsors
lead

Alvotech Swiss AG

INDUSTRY