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Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND (ALVOBOND)

Primary Purpose

Osteoporosis, Postmenopausal

Status

Active

Phase

Phase 3

Locations

South Africa

Study Type

Interventional

Intervention

denosumab

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal focused on measuring Postmenopausal Osteoporosis, Denosumab, Alvotech

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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), total hip, and/or femoral neck.
Age: ≥50 years.
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
Willing to receive calcium plus vitamin D supplements.
No history or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the Investigator, would pose a risk to subject

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
Any current active infections, including localized infections, or any recent history of active infections or a history of recurrent or

Sites / Locations

PHOENIX Pharma(Pty)Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AVT03

Prolia

Arm Description

AVT03 is the proposed biosimilar for Prolia. Subjects in this arm will receive AVT03 60mg administered s.c. on Day 1 and Day 180/Month 6. At Month 12, subjects in the AVT03 arm will receive a third dose of AVT03 60 mg

Subjects will receive 60mg of commercially available Prolia, administered s.c. on Day 1 and Day 180/Month 6. At Month 12, subjects in the Prolia treatment group will be re-randomized in a 1:1 ratio to receive either: Group 2a:Subjects will receive AVT03 60 mg administered s.c. on Day365. Group 2b:Subjects will receive Prolia 60 mg administered s.c. on Day365.

Outcomes

Primary Outcome Measures

To demonstrate clinical similarity of AVT03 and Prolia® in terms percent change from Baseline in Bone Mineral Density (BMD) at 12 months.

Percent change from Baseline in lumbar spine (LS) BMD at 12 months

Secondary Outcome Measures

Percent change from Baseline in LS BMD

Percent change from Baseline in LS BMD at 6 and 18 months

Percent change from Baseline in hip and femoral neck BMD

Percent change from Baseline in hip and femoral neck BMD at Month 6, 12 and 18

Incidence of new morphometric vertebral fractures

Incidence of new morphometric vertebral fractures at 12 and 18 months

Full Information

NCT ID

NCT05395091

First Posted

May 24, 2022

Last Updated

October 11, 2023

Sponsor

Alvotech Swiss AG

1. Study Identification

Unique Protocol Identification Number

NCT05395091

Brief Title

Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

Acronym

ALVOBOND

Official Title

Randomized, Double-Blind, Parallel Design, 2-arm, Multicenter Study Assessing the Biosimilarity of AVT03 and US-Prolia® in Postmenopausal Women With Osteoporosis ( ALVOBOND )Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 23, 2022 (Actual)

Primary Completion Date

May 10, 2024 (Anticipated)

Study Completion Date

October 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alvotech Swiss AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, and PK profiles of AVT03 and Prolia in postmenopausal women with osteoporosis. After the screening activities, eligible subjects were randomized in a 1:1 ratio to receive either AVT03 60 mg or Prolia® 60 mg, administered as a subcutaneous (s.c.) injection on Day 1 and Day 180 (Month 6). At Month 12, subjects in AVT03 treatment group will receive a third dose of AVT03 60 mg administered s.c. while subjects in Prolia® treatment group will be re-randomized in a 1:1 ratio to receive either Prolia 60 mg or AVT03 60 mg on Day 365 (Month 12), administered as a subcutaneous injection. Afterwards, the subjects will be followed until the End of Study (EoS) Visit at Month 18 (ie, 6 months after the last dose at Month 12). 32 clinical sites are now participating in this study and total of 532 patients have been randomized. Ccountries : Bulgaria, Czech Republic, Georgia, Poland, South Africa.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Postmenopausal

Keywords

Postmenopausal Osteoporosis, Denosumab, Alvotech

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

532 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AVT03

Arm Type

Experimental

Arm Description

Arm Title

Prolia

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

denosumab

Other Intervention Name(s)

Prolia

Intervention Description

AVT03 (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL developed as a subcutaneous injection.

Primary Outcome Measure Information:

Title

To demonstrate clinical similarity of AVT03 and Prolia® in terms percent change from Baseline in Bone Mineral Density (BMD) at 12 months.

Description

Percent change from Baseline in lumbar spine (LS) BMD at 12 months

Time Frame

Month 12

Secondary Outcome Measure Information:

Title

Percent change from Baseline in LS BMD

Description

Percent change from Baseline in LS BMD at 6 and 18 months

Time Frame

Month 18

Title

Percent change from Baseline in hip and femoral neck BMD

Description

Percent change from Baseline in hip and femoral neck BMD at Month 6, 12 and 18

Time Frame

Month 6, Month 12, Month 18

Title

Incidence of new morphometric vertebral fractures

Description

Incidence of new morphometric vertebral fractures at 12 and 18 months

Time Frame

Month 12 and 18

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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), 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. No history or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the Investigator, would pose a risk to subject 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 Any current active infections, including localized infections, or any recent history of active infections or a history of recurrent or

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roshan Dias

Organizational Affiliation

Alvotech Swiss AG

Official's Role

Study Director

Facility Information:

Facility Name

PHOENIX Pharma(Pty)Ltd

City

Port Elizabeth

State/Province

Gqeberha

ZIP/Postal Code

6001

Country

South Africa

12. IPD Sharing Statement

Learn more about this trial

Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

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