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

Postmenopausal Women With Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757376
• Other study ID #: CT-P41 3.1
• Secondary ID: 2020-005974-91
• Status: Completed
• Phase: Phase 3
• Start date: June 17, 2021
• Est. completion date: November 16, 2023

Study information

• Verified date: August 2023
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: November 16, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Postmenopausal Women With Osteoporosis

Intervention

Biological:
• CT-P41
60 mg/mL single dose, Solution for injection in PFS
• US-licensed Prolia
60 mg/mL single dose, Solution for injection in PFS

Locations

Country	Name	City	State
Estonia	KLV Arstikabinet	Parnu

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	demonstrate efficacy equivalence	percent change from baseline in bone mineral density (BMD) for lumbar spine (L1 to L4)	Week 52
Primary	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