Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

Phase 3

Completed

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Biological: AVT03; Biological: Denosumab

• Registration Number: NCT05395091
• Lead Sponsor: Alvotech Swiss AG

Brief Summary

This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in postmenopausal women with osteoporosis.

Detailed Description

After the screening activities, eligible subjects were randomized to receive either AVT03 60 mg or Prolia® 60 mg, administered as a subcutaneous (s.c.) injection on Day 1 and at Month 6. At Month 12, subjects in AVT03 treatment group will received a third dose of AVT03 60 mg administered s.c. while subjects in Prolia® treatment group will were be re-randomized 1:1 to receive either Prolia 60 mg or AVT03 60 mg administered as a subcutaneous injection.

Afterwards, the subjects will be followed until the End of Study (EoS) Visit.

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Study Start: 2022-08-23
• Primary Completion: 2024-05-07
• Study Completion: 2024-10-28
• Results First Submitted: 2025-04-23
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Results First Posted: 2025-05-29
• Last Update Posted: 2025-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 532

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AVT03	AVT03	AVT03 is the proposed biosimilar for Prolia.
Prolia	Denosumab	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®.	Baseline to Month 12	Percent Change From Baseline in LS BMD at Month 12 to demonstrate comparable efficacy of AVT03 and Prolia®.
To Demonstrate Comparable Profile of AVT03 and Prolia in Terms of Area Under the Percent Change From Baseline in Serum C-telopeptide of Type 1 Collagen (AUEC of %Cfb sCTX-1)	Baseline to Month 6

Secondary Outcome Measures

Name	Time	Method
Incidence of New Morphometric Vertebral Fractures	Month 12 and 18	Incidence of new morphometric vertebral fractures at 12 and 18 months
Percent Change From Baseline in sCTX-1	Month 3, Month 6, Month 9, Month 12 and Month 18	Percent change from Baseline in sCTX-1 at 3, 6, 9, 12 and 18 months
Incidence, Nature and Severity of Adverse Events Including Adverse Drug Reactions	Month 18
Frequency and Severity of Injection Site Reactions	Month 12
Frequency and Severity of Findings in Routine Safety Parameters	Month 18
Frequency and Titer of Anti-drug Antibodies and Frequency of Neutralizing Antibodies Against AVT03 and Prolia	Month 18
Serum Trough Concentration of AVT03 and Prolia	Month 18
Percent Change From Baseline in LS BMD	Month 6, Month18	Percent change from Baseline in LS BMD at 6 and 18 months
Percent Change From Baseline in Hip and Femoral Neck BMD	Month 6, Month 12, Month 18	Percent change from Baseline in hip and femoral neck BMD at Month 6, 12 and 18 months

Trial Locations

Locations (34)

Investigational Site 3501; 🇧🇬 Plovdiv, Bulgaria

Investigational Site 3503; 🇧🇬 Plovdiv, Bulgaria

Investigational Site 3502; 🇧🇬 Stara Zagora, Bulgaria

Investigational Site 4201; 🇨🇿 Praha, 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

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