Official Title: “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”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Alendronate
  • Alendronate 70mgm once a week for one year

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: placebo

Primary Measures

• Bone marrow Density and xrays
  • Time Frame: ONE YEAR
    
• Bone marrow density
  • Time Frame: ONE YEAR
    

Secondary Measures

• Blood and urine to check liver,kidney,thyroid functions. PSA and bone markers will also be checked
  • Time Frame: every 4 months
    

Inclusion Criteria:

• Histologically/cytologically proven, non-metastatic (M0) adenocarcinoma of the prostate.
• Life expectancy of > 12 months.
• Initiation of treatment with the luteinizing hormone-releasing hormone agonist (LHRH-a) Lupron no more than 15 days prior or 30 days following, baseline visit.
• Requiring treatment with LHRH agonists for prostate cancer, for a duration of at least 12 months from baseline.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• Prior to any study-specific procedures, subject (and/or their legally authorized representative) has voluntarily signed and dated an informed consent form.

Exclusion Criteria:

• Bone Metastases Current or previous use with in past 12 months of bisphosphonate. Known hypersensitivity to LHRH. Hypocalcaemia. Severe renal impairment, Abnormal liver function, Hypothyroidism, Hyperthyroidism, Bilateral hip replacement.
• Use of LHRH or anti-androgen medication within last 12 months. Abnormalities of esophagus which delay esophageal emptying. Inability to stand or sit upright for at least 30 minutes.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Canadian Urology Research Consortium

Overall Clinical Trial Officials and Contacts

Laurence Klotz Principal Investigator Canadian Urology Research Consortium  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00236002

Study ID Number: ACA-CANA-04-012

ClinicalTrials.gov Identifier: NCT00236002

Health Authority: Canada: Health Canada