Status:
COMPLETED
Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
Lead Sponsor:
Alvotech Swiss AG
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
50+ years
Phase:
PHASE3
Brief 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 AVT...
Detailed 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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
Key Trial Info
Start Date :
August 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2024
Estimated Enrollment :
532 Patients enrolled
Trial Details
Trial ID
NCT05395091
Start Date
August 23 2022
End Date
October 28 2024
Last Update
May 29 2025
Active Locations (34)
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1
Investigational Site 3501
Plovdiv, Bulgaria
2
Investigational Site 3503
Plovdiv, Bulgaria
3
Investigational Site 3502
Stara Zagora, Bulgaria
4
Investigational Site 4201
Prague, Czechia