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

Launched by CELLTRION · Feb 12, 2021

Keywords

ClinConnect Summary

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.

Gender

FEMALE

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