NCT00236002

Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )

A Phase III, Double-blind, Randomized, Parallel Group, Placebo-controlled Study of Oral Fosamax, 70 mg Once a Week, for the Prevention of Androgen Deprivation Bone Loss in Non-metastatic Prostate Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Canadian Urology Research Consortium · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multi-center,double blind randomized phase III placebo controlled study in 250 men with histologically proven prostate cancer with out bone metastases who are beginning ADT therapy and who will receive concomitant treatment with either oral Fosamax 70mg once weekly or placebo for one year.These men will be treated and follow up for one year,during which time changes in BMD, markers of bone resorption and formation will be monitored.All patients will receive calcium and vitamin D through out the study.

Detailed description

This is a phase three multicentre, double blind, randomize parallel group, placebo-controlled study in 250 men with histologically proven cancer without bone metastases who are beginning ADT therapy and who will receive a concomitant treatment with either oral Fosamax 70 mg once a weak (n=125) or placebo (n=125) for one year. Changes in BMD, markers of bone absorption and formation are monitored.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Alendronate	Alendronate 70mgm once a week for one year

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-11-01
• Completion: 2009-08-01
• First posted: 2005-10-12
• Last updated: 2009-08-12