Osteoporosis, PostmenopausalPhase 3ALVOBONDNCT05395091
Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
A Phase 3 study testing AVT03 and Denosumab in people with Osteoporosis, Postmenopausal, run by Alvotech Swiss AG at 34 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- AVT03 and Denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 34 sitesin 5 countries
- Study dates
- 23 Aug 2022to 28 Oct 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Evidence of clinically relevant pathology, especially prior diagnosis of bone disease, or any uncontrolled condition that will affect bone metabolism
- History and/or presence of 1 severe or more than 1 moderate vertebral fractures confirmed by x-ray.
- History of hip fracture
- Presence of active healing fractures
- Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures
- Evidence of hypo/hypercalcemia at Screening
- Known vitamin D deficiency
- Known intolerance to calcium and vitamin D supplement.
Trial locations and contacts
34 sites in 5 countries.
34 sites in 5 countries
South Africa12 sites
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
Poland11 sites
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
Georgia6 sites
Investigational Site 9901
Tbilisi
Investigational Site 9902
Tbilisi
Investigational Site 9903
Tbilisi
Investigational Site 9904
Tbilisi
Investigational Site 9905
Tbilisi
Investigational Site 9906
Tbilisi
Bulgaria3 sites
Investigational Site 3501
Plovdiv
Investigational Site 3503
Plovdiv
Investigational Site 3502
Stara Zagora
Czechia2 sites
Investigational Site 4201
Prague
Investigational Site 4202
Uherské Hradiště
About this study
Official title: A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women With Osteoporosis, ALVOBOND
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.
Read the 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.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- AVT03, Denosumab
- Keywords
- Postmenopausal Osteoporosis, Denosumab, Alvotech
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVT03Biological
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.
DenosumabBiological
Also called Prolia
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.
| Study group | Role | What they receive |
|---|---|---|
| AVT03 | Experimental | AVT03 is the proposed biosimilar for Prolia. Receives: Biological: AVT03 |
| Prolia | Active comparator | Not described Receives: Biological: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®.
Percent Change From Baseline in LS BMD at Month 12 to demonstrate comparable efficacy of AVT03 and Prolia®.
Measured: Baseline to Month 12
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)
Measured: Baseline to Month 6
Secondary outcomes (9)
Percent Change From Baseline in LS BMD
Percent change from Baseline in LS BMD at 6 and 18 months
Measured: Month 6, Month18
Percent Change From Baseline in Hip and Femoral Neck BMD
Percent change from Baseline in hip and femoral neck BMD at Month 6, 12 and 18 months
Measured: Month 6, Month 12, Month 18
Incidence of New Morphometric Vertebral Fractures
Incidence of new morphometric vertebral fractures at 12 and 18 months
Measured: Month 12 and 18
Percent Change From Baseline in sCTX-1
Percent change from Baseline in sCTX-1 at 3, 6, 9, 12 and 18 months
Measured: Month 3, Month 6, Month 9, Month 12 and Month 18
Incidence, Nature and Severity of Adverse Events Including Adverse Drug Reactions
Measured: Month 18
Frequency and Severity of Injection Site Reactions
Measured: Month 12
Frequency and Severity of Findings in Routine Safety Parameters
Measured: Month 18
Frequency and Titer of Anti-drug Antibodies and Frequency of Neutralizing Antibodies Against AVT03 and Prolia
Measured: Month 18
Serum Trough Concentration of AVT03 and Prolia
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start23 Aug 2022
- Primary completion7 May 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvotech Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felicitas Bullo, Study director, Alvotech Swiss AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395091
- Sponsor's protocol ID
- AVT03-GL-C01
- Acronym
- ALVOBOND
- Status last verified
- May 2025
- First submitted
- 24 May 2022
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40698538
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women With Osteoporosis, ALVOBOND
- ClinicalTrials.gov ID
- NCT05395091
- Acronym / sponsor ID
- ALVOBOND / AVT03-GL-C01
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Postmenopausal Osteoporosis, Denosumab, Alvotech
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Alvotech Swiss AGIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Posted 29 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVT03 | Experimental | Biological: AVT03AVT03 is the proposed biosimilar for Prolia. |
| Prolia | Active comparator | Biological: Denosumab |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Evidence of clinically relevant pathology, especially prior diagnosis of bone disease, or any uncontrolled condition that will affect bone metabolism
- History and/or presence of 1 severe or more than 1 moderate vertebral fractures confirmed by x-ray.
- History of hip fracture
- Presence of active healing fractures
- Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVT03AVT03 (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 | AVT03 |
| DenosumabAlso: ProliaProlia (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. | Biological | Prolia |
Primary outcome
Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®.
Time frame: 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)
Time frame: Baseline to Month 6
9 secondary outcomes
Percent Change From Baseline in LS BMD
Time frame: Month 6, Month18
Percent Change From Baseline in Hip and Femoral Neck BMD
Time frame: Month 6, Month 12, Month 18
Incidence of New Morphometric Vertebral Fractures
Time frame: Month 12 and 18
Percent Change From Baseline in sCTX-1
Time frame: Month 3, Month 6, Month 9, Month 12 and Month 18
Incidence, Nature and Severity of Adverse Events Including Adverse Drug Reactions
Time frame: Month 18
Frequency and Severity of Injection Site Reactions
Time frame: Month 12
Frequency and Severity of Findings in Routine Safety Parameters
Time frame: Month 18
Frequency and Titer of Anti-drug Antibodies and Frequency of Neutralizing Antibodies Against AVT03 and Prolia
Time frame: Month 18
Serum Trough Concentration of AVT03 and Prolia
Time frame: Month 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40698538Lortkipanidze 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felicitas Bullo study director
Alvotech Swiss AG
34 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AVT03 and Denosumab in people with Osteoporosis, Postmenopausal, run by Alvotech Swiss AG at 34 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in South Africa, Poland, Georgia, Bulgaria, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®. (time frame: Baseline to Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05395091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.