Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

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.

• 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.