Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129142
Status:
COMPLETED
Last Update Posted:
2013-11-15
First Post:
2005-08-09
Brief Title:
Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy
Sponsor:
GTx
Organization:
GTx
Study Overview
Official Title:
A Randomized Double Blind Placebo Controlled Multicenter Efficacy and Safety Study of Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy
Status:
COMPLETED
Status Verified Date:
2013-11
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:
Androgen deprivation therapy ADT treatment for prostate cancer decreases the natural hormone called testosterone This type of therapy is very effective for the treatment of prostate cancer However one of the side effects is bone loss or thinning of the bones that can lead to osteoporosis and an increased risk of bone fractures breaking of the bones The purpose of the study is to determine whether or not the addition of toremifene citrate the study drug to therapy can prevent or decrease the number of bone fractures and to evaluate its impact on side effects associated with testosterone reduction therapy
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