NCT00129142

Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (planned)
• Sponsor: GTx · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Osteoporosis
• Fractures

Interventions

Type	Name	Description
DRUG	Toremifene Citrate

Timeline

• Start date: 2003-10-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2005-08-11
• Last updated: 2013-11-15

Locations

155 sites across 2 countries: United States, Mexico