Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05395091 | Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND | PHASE3 | COMPLETED | 532 | — | — | Aug 23, 2022 | Oct 28, 2024 | May 29, 2025 | 34 | Bulgaria, Czechia +3 |
Percent Change From Baseline in LS BMD at Month 12 to demonstrate comparable efficacy of AVT03 and Prolia®.
| Arm | Type | Description |
|---|---|---|
| AVT03 | EXPERIMENTAL | AVT03 is the proposed biosimilar for Prolia. |
| Prolia | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AVT03 | BIOLOGICAL | 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 | BIOLOGICAL | 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. |
1. Postmenopausal women with osteoporosis willing to sign an informed consent form (ICF)and able to undergo protocol related procedures. 2. A baseline dual-energy x-ray absorptiometry (DXA) scan with a T score ≤-2.5 and * 4.0 at the LS (L1 to L4)and/or, total hip, and/or femoral neck. 3. Age: ≥5...