NCT00426777

Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer

A Randomized, Single-blind, Placebo-controlled, Multicentre Study to Evaluate the Effect of Risedronate and Placebo on Bone Mineral Density in Men Undergoing Androgen Deprivation Therapy With Leuprolide Acetate

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: CMX Research · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prostate cancer patients treated with LHRH agonists (e.g., leuprolide) lose bone mineral density. This is similar to post-menopausal osteoporosis. Risedronate is approved to prevent osteoporosis. We hypothesize that risedronate may also be effective in prostate cancer patients treated with LHRH agonists.

Detailed description

IV bisphosphonates have proven effective in treating bone loss in prostate cancer patients treated with LHRH agonists. However, it is yet to be determined if an oral bisphosphonate such as risedronate could offer the same benefits.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	risedronate	risedronate 35mg tablet, weekly for 12 months
DRUG	risedronate	35mg weekly
DRUG	Control	risedronate-matched placebo weekly

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-01-01
• Completion: 2009-02-01
• First posted: 2007-01-25
• Last updated: 2012-02-03

Locations

21 sites across 1 country: Canada