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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Postmenopausal Women With Osteoporosis

Intervention / Treatment
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* Biological: CT-P41
* Biological: US-licensed Prolia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P41<br>60 mg/mL single dose administration, Solution for injection in prefilled syringe(PFS) | Biological: CT-P41<br>* 60 mg/mL single dose, Solution for injection in PFS<br>|
| Active Comparator: US-licensed Prolia<br>60 mg/mL single dose administration, Solution for injection in PFS | Biological: US-licensed Prolia<br>* 60 mg/mL single dose, Solution for injection in PFS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| demonstrate efficacy equivalence | percent change from baseline in bone mineral density (BMD) for lumbar spine (L1 to L4) | Week 52 | 
| demonstrate pharmacodynamics(PD) similarity | area under the effect curve (AUEC) of serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX) | from Day 1 predose to Week 26 predose |