Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04757376
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2021-02-12
Brief Title:
A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
Sponsor:
Celltrion
Organization:
Celltrion
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1000 mg of elemental calcium and at least 400 IU vitamin D from randomization to EOS visit and the data will be collected via patients diary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005974-91 | EUDRACT_NUMBER | None | None |