Phase 3 N=532 Randomized Quadruple-blind Treatment

Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

Osteoporosis, Postmenopausal

Bottom Line

View on ClinicalTrials.gov: NCT05395091 ↗

Enrolled (actual)

532

Serious AEs

2.9%

Results posted

May 2025

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: AVT03 (Biological); Denosumab (Biological)
Age: Adult, Older Adult · 50+ yrs
Sex: Female
Sponsor: Alvotech Swiss AG
Primary completion: May 2024

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	—	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05395091). 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.