Phase 3
Completed N=532
Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
Osteoporosis, Postmenopausal
Source: ClinicalTrials.gov NCT05395091 ↗
Enrolled (actual)
532
Serious AEs
2.9%
Results posted
May 2025
Primary outcomePrimary: Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®. — 5.3; 5.18 Percent Change From Baseline in LS BMD
◆ Published Evidence
Emerging
4citations · ~4 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®. |
5.3; 5.18 | — |
| PRIMARY 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) |
2345.55; 2342.87 | — |
| SECONDARY Percent Change From Baseline in LS BMD |
— | — |
| SECONDARY Percent Change From Baseline in Hip and Femoral Neck BMD |
— | — |
| SECONDARY Incidence of New Morphometric Vertebral Fractures |
— | — |
| SECONDARY Percent Change From Baseline in sCTX-1 |
— | — |
| SECONDARY Incidence, Nature and Severity of Adverse Events Including Adverse Drug Reactions |
— | — |
| SECONDARY Frequency and Severity of Injection Site Reactions |
— | — |
| SECONDARY Frequency and Severity of Findings in Routine Safety Parameters |
— | — |
| SECONDARY Frequency and Titer of Anti-drug Antibodies and Frequency of Neutralizing Antibodies Against AVT03 and Prolia |
— | — |
| SECONDARY Serum Trough Concentration of AVT03 and Prolia |
— | — |
Eligibility Criteria
- Postmenopausal women with osteoporosis willing to sign an informed consent form (ICF)and able to undergo protocol related procedures.
- 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.
- Age: ≥50 years.
- Female subject is postmenopausal according to 1 of the following criteria:
- Spontaneous amenorrhea for ≥12 consecutive months
- Biochemical criteria of menopause, follicle-stimulating hormone, >40 IU/L except surgically sterile
- Having had bilateral oophorectomy ≥6 weeks prior to Screening
- Willing to receive calcium plus vitamin D supplements.
- At least 2 consecutive evaluable lumbar vertebrae and at least 1 evaluable hip.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05395091) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.