Multicenter Study in Postmenopausal Women with Osteoporosis, ALVOBOND
- Conditions
- Osteoporosis, Postmenopausal
- Interventions
- 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 At Month 12, subjects in AVT03 treatment group will receive a third dose of AVT03 60 mg administered s.c. while subjects in Prolia® treatment group will be re-randomized 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 532
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prolia Denosumab - AVT03 AVT03 AVT03 is the proposed biosimilar for Prolia.
- Primary Outcome Measures
Name Time Method To demonstrate clinical similarity of AVT03 and Prolia® in terms of change in Bone Mineral Density (BMD). Month 12 Change in BMD
To demonstrate clinical similarity 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) Month 6
- Secondary Outcome Measures
Name Time Method Percent change from Baseline in LS BMD Month 18 Percent change from Baseline in LS BMD at 6 and 18 months
Incidence, nature and severity of adverse events including adverse drug reactions Month 18 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
Incidence of new morphometric vertebral fractures Month 12 and 18 Incidence of new morphometric vertebral fractures at 12 and 18 months
Frequency and severity of injection site reactions Month 12 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 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
Frequency and severity of findings in routine safety parameters Month 18
Trial Locations
- Locations (34)
Investigational Site 9903
🇬🇪Tbilisi, Georgia
Investigational Site 9905
🇬🇪Tbilisi, Georgia
Investigational Site 4810
🇵🇱Zamość, Poland
Investigational Site 2714
🇿🇦Cape Town, South Africa
Investigational Site 2710
🇿🇦Groenkloof, South Africa
Investigational Site 2711
🇿🇦Parow, South Africa
Investigational Site 2706
🇿🇦Pretoria, South Africa
Investigational Site 2701
🇿🇦Port Elizabeth, South Africa
Investigational Site 2703
🇿🇦Worcester, South Africa
Investigational Site 3501
🇧🇬Plovdiv, Bulgaria
Investigational Site 4804
🇵🇱Białystok, Poland
Investigational Site 3503
🇧🇬Plovdiv, Bulgaria
Investigational Site 9901
🇬🇪Tbilisi, Georgia
Investigational Site 9902
🇬🇪Tbilisi, Georgia
Investigational Site 4803
🇵🇱Białystok, Poland
Investigational Site 4802
🇵🇱Kraków, Poland
Investigational Site 4806
🇵🇱Łódź, Poland
Investigational Site 9906
🇬🇪Tbilisi, Georgia
Investigational Site 4807
🇵🇱Kraków, Poland
Investigational Site 4801
🇵🇱Skierniewice, Poland
Investigational Site 9904
🇬🇪Tbilisi, Georgia
Investigational Site 4812
🇵🇱Poznań, Poland
Investigational Site 4809
🇵🇱Warsaw, Poland
Investigational Site 4805
🇵🇱Świdnik, Poland
Investigational Site 3502
🇧🇬Stara Zagora, Bulgaria
Investigational Site 4201
🇨🇿Praha, Czechia
Investigational Site 4202
🇨🇿Uherské Hradiště, Czechia
Investigational Site 4811
🇵🇱Lublin, Poland
Investigational Site 2705
🇿🇦Bloemfontein, South Africa
Investigational Site 2708
🇿🇦Centurion, South Africa
Investigational Site 2707
🇿🇦Centurion, South Africa
Investigational Site 2712
🇿🇦Johannesburg, South Africa
Investigational Site 2702
🇿🇦Kwadukuza, South Africa
Investigational Site 2713
🇿🇦Pretoria, South Africa