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

NCT ID: NCT04757376

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 479 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2023-11-16

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.

Conditions

Postmenopausal Women With Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CT-P41

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

Group Type: EXPERIMENTAL

CT-P41

Intervention Type: BIOLOGICAL

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

US-licensed Prolia

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

Group Type: ACTIVE_COMPARATOR

US-licensed Prolia

Intervention Type: BIOLOGICAL

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

Interventions

CT-P41

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

Intervention Type: BIOLOGICAL

US-licensed Prolia

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Women, 50 to 80 years of age, both inclusive.

2. Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.

3. Postmenopausal

4. 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.

5. 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.

6. Patient with albumin-adjusted total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) at Screening.

Exclusion Criteria

1. Patient previously received denosumab, any other monoclonal antibodies, or biologic agents for osteoporosis

2. Patient confirmed or suspected with infection of COVID-19 at Screening, or has contact with COVID-19 patient within 14 days from Screening

3. Patient with history and/or presence of one severe or > 2 moderate vertebral fractures as determined by central reading of lateral spine X-ray

4. Patient with history and/or presence of hip fracture

5. Patient with history and/or presence of hyperparathyroidism or hypoparathyroidism, irrespective of current controlled or uncontrolled status

6. Patient with current hyperthyroidism (unless well controlled on stable antithyroid therapy)

7. Patient with current hypothyroidism (unless well controlled on stable thyroid replacement therapy)

8. Patient with history and/or presence of bone disease and metabolic disease (except for osteoporosis) that may interfere with the interpretation of the results

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Celltrion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center For Clinical And Basic Research

Tallinn, Harju, Estonia

East Tallinn Central Hospital-Ravi 18

Tallinn, Harju, Estonia

Clinical Research Centre Ltd

Tartu, Tartu, Estonia

KLV Arstikabinet

Pärnu, , Estonia

Health Center Association, Medical Center Liepaja

Liepāja, , Latvia

Health Center 4-117 K. Barona Str

Riga, , Latvia

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

Poznan, Greater Poland Voivodeship, Poland

Centrum Medyczne Poznan - PRATIA - PPDS

Skórzewo, Greater Poland Voivodeship, Poland

Krakowskie Centrum Medyczne

Krakow, Lesser Poland Voivodeship, Poland

AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

Wroclaw, Lower Silesian Voivodeship, Poland

SOMED CR Sp. z o.o. Sp. Komandytowa - Lodz

Lódz, Lódzkie, Poland

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie

Warsaw, Masovian Voivodeship, Poland

SOMED CR Sp. z o.o. Sp. Komandytowa - Warszawa

Warsaw, Masovian Voivodeship, Poland

NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik

Bialystok, Podlaskie Voivodeship, Poland

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni

Gdynia, Pomeranian Voivodeship, Poland

MCM Krakow - PRATIA - PPDS

Krakow, , Poland

AES - AS - Medical Center of Edelweiss Medics LLC

Kyiv, , Ukraine

Clinic of SI Institute of Gerontology n.a. D.F.Chebotaryov of NAMS of Ukraine

Kyiv, , Ukraine

AES - AS - Medical Center of Medbud - Clinic LLC

Kyiv, , Ukraine

Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov

Vinnytsia, , Ukraine

Countries

Estonia; Latvia; Poland; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-005974-91

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CT-P41 3.1

Identifier Type: -

Identifier Source: org_study_id