Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

Alvotech

Status and phase: Completed; Phase 3

Conditions: Osteoporosis, Postmenopausal

Treatments: Biological: Denosumab; Biological: AVT03

Study type: Interventional

Funder types: Industry

Identifiers

NCT05395091

AVT03-GL-C01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 532 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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: ≥50 years.

4. Female subject is postmenopausal according to 1 of the following criteria:

   1. Spontaneous amenorrhea for ≥12 consecutive months
   2. Biochemical criteria of menopause, follicle-stimulating hormone, >40 IU/L except surgically sterile
   3. Having had bilateral oophorectomy ≥6 weeks prior to Screening

5. Willing to receive calcium plus vitamin D supplements.

6. At least 2 consecutive evaluable lumbar vertebrae and at least 1 evaluable hip.

Exclusion Criteria

1. Evidence of clinically relevant pathology, especially prior diagnosis of bone disease, or any uncontrolled condition that will affect bone metabolism
2. History and/or presence of 1 severe or more than 1 moderate vertebral fractures confirmed by x-ray.
3. History of hip fracture
4. Presence of active healing fractures
5. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures
6. Evidence of hypo/hypercalcemia at Screening
7. Known vitamin D deficiency
8. Known intolerance to calcium and vitamin D supplement.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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532 participants in 2 patient groups

AVT03

Experimental group

Description:

AVT03 is the proposed biosimilar for Prolia.

Treatment:

Biological: AVT03

Prolia

Active Comparator group

Treatment:

Biological: Denosumab