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A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

Primary Purpose

Postmenopausal Women With Osteoporosis

Status

Active

Phase

Phase 3

Locations

Estonia

Study Type

Interventional

Intervention

CT-P41

US-licensed Prolia

About this trial

This is an interventional treatment trial for Postmenopausal Women With Osteoporosis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women, 50 to 80 years of age, both inclusive.
Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
Postmenopausal
Bone mineral density T-score ≤ - 2.5 and ≥ - 4.0 at the lumbar spine (L1 to L4) as assessed by the central imaging vendor based on dual-energy X-ray absorptiometry(DXA) scan.
Patients must have at least 3 vertebrae considered evaluable at the lumbar spine (L1 to L4) and at least 1 hip considered evaluable by DXA scan assessed by the central imaging vendor. Patients with unilateral metal in hips that would be allowed for the other side of 1 evaluable hip are included.
Patient with albumin-adjusted total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) at Screening.

Exclusion Criteria:

Patient with a hypersensitivity to any component of denosumab or dry natural rubber.
Patient with history and/or presence of one severe or > 2 moderate vertebral fractures as determined by central reading of lateral spine X-ray
Patient with history and/or presence of hip fracture
Patient with history and/or presence of hyperparathyroidism or hypoparathyroidism, irrespective of current controlled or uncontrolled status
Patient with current hyperthyroidism (unless well controlled on stable antithyroid therapy)
Patient with current hypothyroidism (unless well controlled on stable thyroid replacement therapy)
Patient with history and/or presence of bone disease and metabolic disease (except for osteoporosis) that may interfere with the interpretation of the results
Patient with history and/or concurrent use of any osteoporosis treatment (other than calcium and vitamin D supplements), oral or parenteral glucocorticosteroids, any bone active drugs, and any investigational drug

Sites / Locations

KLV Arstikabinet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CT-P41

US-licensed Prolia

Arm Description

60 mg/mL single dose administration, Solution for injection in prefilled syringe(PFS)

60 mg/mL single dose administration, Solution for injection in PFS

Outcomes

Primary Outcome Measures

demonstrate efficacy equivalence

percent change from baseline in bone mineral density (BMD) for lumbar spine (L1 to L4)

demonstrate pharmacodynamics(PD) similarity

area under the effect curve (AUEC) of serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX)

Secondary Outcome Measures

Full Information

NCT ID

NCT04757376

First Posted

February 12, 2021

Last Updated

August 13, 2023

Sponsor

Celltrion

1. Study Identification

Unique Protocol Identification Number

NCT04757376

Brief Title

A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

Official Title

A Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 17, 2021 (Actual)

Primary Completion Date

May 18, 2023 (Actual)

Study Completion Date

November 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celltrion

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis

Detailed Description

This is a double-blind, randomized, active-controlled, Phase 3 study to evaluate the efficacy, PK, PD, and safety including immunogenicity of CT-P41 compared with US-licensed Prolia in postmenopausal women with osteoporosis. All patients will also receive daily supplementation containing at least 1,000 mg of elemental calcium and at least 400 IU vitamin D from randomization to EOS visit and the data will be collected via patient's diary.

6. Conditions and Keywords

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

Postmenopausal Women With Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

479 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CT-P41

Arm Type

Experimental

Arm Description

60 mg/mL single dose administration, Solution for injection in prefilled syringe(PFS)

Arm Title

US-licensed Prolia

Arm Type

Active Comparator

Arm Description

60 mg/mL single dose administration, Solution for injection in PFS

Intervention Type

Biological

Intervention Name(s)

CT-P41

Intervention Description

60 mg/mL single dose, Solution for injection in PFS

Intervention Type

Biological

Intervention Name(s)

US-licensed Prolia

Intervention Description

60 mg/mL single dose, Solution for injection in PFS

Primary Outcome Measure Information:

Title

demonstrate efficacy equivalence

Description

percent change from baseline in bone mineral density (BMD) for lumbar spine (L1 to L4)

Time Frame

Week 52

Title

demonstrate pharmacodynamics(PD) similarity

Description

area under the effect curve (AUEC) of serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX)

Time Frame

from Day 1 predose to Week 26 predose

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women, 50 to 80 years of age, both inclusive. Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth. Postmenopausal Bone mineral density T-score ≤ - 2.5 and ≥ - 4.0 at the lumbar spine (L1 to L4) as assessed by the central imaging vendor based on dual-energy X-ray absorptiometry(DXA) scan. Patients must have at least 3 vertebrae considered evaluable at the lumbar spine (L1 to L4) and at least 1 hip considered evaluable by DXA scan assessed by the central imaging vendor. Patients with unilateral metal in hips that would be allowed for the other side of 1 evaluable hip are included. Patient with albumin-adjusted total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) at Screening. Exclusion Criteria: Patient previously received denosumab, any other monoclonal antibodies, or biologic agents for osteoporosis Patient confirmed or suspected with infection of COVID-19 at Screening, or has contact with COVID-19 patient within 14 days from Screening Patient with history and/or presence of one severe or > 2 moderate vertebral fractures as determined by central reading of lateral spine X-ray Patient with history and/or presence of hip fracture Patient with history and/or presence of hyperparathyroidism or hypoparathyroidism, irrespective of current controlled or uncontrolled status Patient with current hyperthyroidism (unless well controlled on stable antithyroid therapy) Patient with current hypothyroidism (unless well controlled on stable thyroid replacement therapy) Patient with history and/or presence of bone disease and metabolic disease (except for osteoporosis) that may interfere with the interpretation of the results

Facility Information:

Facility Name

KLV Arstikabinet

City

Parnu

ZIP/Postal Code

80010

Country

Estonia

12. IPD Sharing Statement

Learn more about this trial

A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

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