Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519857
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2007-08-21
Brief Title:
Trial to Evaluate Tibolone in the Treatment of Osteoporosis P06468
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Multinational Multicenter Randomized Double-Blind Parallel GroupPlacebo Controlled Clinical Trial of the Effects of Tibolone Org OD-14 125mg on the Incidence of New Vertebral Fractures in Osteoporotic 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:
LIFT
Brief Summary:
Tibolone 125 mg is an effective treatment for the prevention of osteoporosis and is expected to be effective in preventing fractures in osteoporotic women Tibolone could be more acceptable for long-term use in particular since it does not induce a regular withdrawal bleed
The objective of this trial is to compare placebo and tibolone a steroid with tissue specific activity in the prevention of spinal fractures in women meeting the WHO criteria for osteoporosis or who have asymptomatic vertebral fractures
The objective of this trial is to compare placebo and tibolone a steroid with tissue specific activity in the prevention of spinal fractures in women meeting the WHO criteria for osteoporosis or who have asymptomatic vertebral fractures
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 |
|---|---|---|---|
| 32962 | None | None | None |