Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
NCT ID: NCT05395091
Last Updated: 2025-05-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
532 participants
INTERVENTIONAL
2022-08-23
2024-10-28
Brief Summary
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Detailed Description
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Afterwards, the subjects will be followed until the End of Study (EoS) Visit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AVT03
AVT03 is the proposed biosimilar for Prolia.
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.
Prolia
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
2. History and/or presence of 1 severe or more than 1 moderate vertebral fractures confirmed by x-ray.
3. History of hip fracture
4. Presence of active healing fractures
5. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures
6. Evidence of hypo/hypercalcemia at Screening
7. Known vitamin D deficiency
8. Known intolerance to calcium and vitamin D supplement.
50 Years
FEMALE
No
Sponsors
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Alvotech Swiss AG
INDUSTRY
Responsible Party
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Principal Investigators
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Felicitas Bullo
Role: STUDY_DIRECTOR
Alvotech Swiss AG
Locations
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Investigational Site 3501
Plovdiv, , Bulgaria
Investigational Site 3503
Plovdiv, , Bulgaria
Investigational Site 3502
Stara Zagora, , Bulgaria
Investigational Site 4201
Prague, , Czechia
Investigational Site 4202
Uherské Hradiště, , Czechia
Investigational Site 9901
Tbilisi, , Georgia
Investigational Site 9902
Tbilisi, , Georgia
Investigational Site 9903
Tbilisi, , Georgia
Investigational Site 9904
Tbilisi, , Georgia
Investigational Site 9905
Tbilisi, , Georgia
Investigational Site 9906
Tbilisi, , Georgia
Investigational Site 4803
Bialystok, , Poland
Investigational Site 4804
Bialystok, , Poland
Investigational Site 4802
Krakow, , Poland
Investigational Site 4807
Krakow, , Poland
Investigational Site 4806
Lodz, , Poland
Investigational Site 4811
Lublin, , Poland
Investigational Site 4812
Poznan, , Poland
Investigational Site 4801
Skierniewice, , Poland
Investigational Site 4805
Świdnik, , Poland
Investigational Site 4809
Warsaw, , Poland
Investigational Site 4810
Zamość, , Poland
Investigational Site 2705
Bloemfontein, , South Africa
Investigational Site 2714
Cape Town, , South Africa
Investigational Site 2707
Centurion, , South Africa
Investigational Site 2708
Centurion, , South Africa
Investigational Site 2710
Groenkloof, , South Africa
Investigational Site 2712
Johannesburg, , South Africa
Investigational Site 2702
KwaDukuza, , South Africa
Investigational Site 2711
Parow, , South Africa
Investigational Site 2701
Port Elizabeth, , South Africa
Investigational Site 2706
Pretoria, , South Africa
Investigational Site 2713
Pretoria, , South Africa
Investigational Site 2703
Worcester, , South Africa
Countries
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References
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Lortkipanidze M, de Villiers T, Kania G, Bullo F, Jaskiewicz L, Stamatakos S, Rai M, Haliduola H, Otto H, Sattar A, Leutz S, Berti F. A randomized, double blind, parallel design, repeat dose, 2-arm, multicenter study comparing the efficacy, safety, immunogenicity, and pharmacokinetic profiles of a denosumab biosimilar, AVT03, in postmenopausal women with osteoporosis. Expert Opin Biol Ther. 2025 Aug;25(8):899-912. doi: 10.1080/14712598.2025.2538609. Epub 2025 Jul 28.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AVT03-GL-C01
Identifier Type: -
Identifier Source: org_study_id
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