Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431431
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2007-02-02
Brief Title:
Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women P06090
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Multinational Randomized Double-Blind Parallel Group Comparative Trial on the Effects of 2 Years Treatment With Tibolone 125 mg Org OD 14 and Raloxifene 60 mg on Bone Mineral Density in Osteopenic Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2022-02
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:
STEP
Brief Summary:
Both tibolone and raloxifene have been demonstrated to prevent postmenopausal bone loss During treatment with tibolone bone mineral density BMD of the spine has been shown to be increased between 18 and 58 above baseline in two years depending on the population studied Since treatments aimed at prevention should ideally be used long-term compliance with the treatment is crucial Efficacy of and compliance with the two treatments will be measured and evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| E-1693 | None | None | None |