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Efficacy and Safety of AVT03 vs Prolia in Postmenopausal Osteoporosis
NCT05395091Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2022
- Primary completion
- May 2024
- Countries
- 5
- Sponsor
- Alvotech
- Modality
- Monoclonal Antibodies
- Drugs
- DenOsteoRel
- Conditions
- osteoporosis
01
Overview
Phase 3, randomised, double-blind trial of DenOsteoRel in osteoporosis (2 arms), sponsored by Alvotech. Primary endpoints: Percent Change From Baseline in Lumbar Spine Bone Mineral Density at 12 months and Area Under the Effect Curve of Percent Change From Baseline in Serum C-telopeptide of Type 1 Collagen at 6 months. Started Aug 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
AVT03 Arm
Receives AVT03 throughout the study.
Prolia Arm
Receives Prolia initially; re-randomized to Prolia or AVT03 at Month 12.
03
Endpoints
Primary
Percent Change From Baseline in Lumbar Spine Bone Mineral Density
Area Under the Effect Curve of Percent Change From Baseline in Serum C-telopeptide of Type 1 Collagen
Secondary
Percent Change From Baseline in Lumbar Spine Bone Mineral Density
Percent Change From Baseline in Hip and Femoral Neck Bone Mineral Density
Incidence of New Morphometric Vertebral Fractures
Percent Change From Baseline in Serum C-telopeptide of Type 1 Collagen
Incidence, Nature and Severity of Adverse Events Including Adverse Drug Reactions
Frequency and Severity of Injection Site Reactions
Frequency and Titer of Anti-drug Antibodies
Serum Trough Concentration of AVT03 and Prolia
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