NCT05395091CompletedPhase 3
Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women With Osteoporosis, ALVOBOND
Source: ClinicalTrials.gov · Last updated 29 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 532 (actual)
- First submitted
- 24 May 2022
- Start date
- 23 Aug 2022
- Primary completion date
- 7 May 2024
- Lead sponsor
- Alvotech Swiss AG
- Diseases
- Osteoporosis
- NCT number
- NCT05395091
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 532
- From 23 Aug 2022 to the primary completion date, 7 May 2024
- 34 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of clinically relevant pathology, especially prior diagnosis of bone disease, or any uncontrolled condition that will affect bone metabolism
Other illness
- History of hip fracture
Lab values
- Known intolerance to calcium and vitamin D supplement.
Other
- History and/or presence of 1 severe or more than 1 moderate vertebral fractures confirmed by x-ray.
- 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
Criteria the registry did not label
- 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.
Age in the registry: 50 years to - · Sex: Female · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.