Status:
COMPLETED
A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
Lead Sponsor:
Celltrion
Conditions:
Postmenopausal Women With Osteoporosis
Eligibility:
FEMALE
50-80 years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2023
Estimated Enrollment :
479 Patients enrolled
Trial Details
Trial ID
NCT04757376
Start Date
June 17 2021
End Date
November 16 2023
Last Update
June 14 2024
Active Locations (20)
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1
Center For Clinical And Basic Research
Tallinn, Harju, Estonia, 10128
2
East Tallinn Central Hospital-Ravi 18
Tallinn, Harju, Estonia, 11312
3
Clinical Research Centre Ltd
Tartu, Tartu, Estonia, 50106
4
KLV Arstikabinet
Pärnu, Estonia, 80010