Official Title: “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”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2009

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.

Intervention(s) in this Clinical Trial

• Drug: risedronate
  • risedronate 35mg tablet, weekly for 12 months
• Drug: risedronate
  • 35mg weekly
• Drug: Control
  • risedronate-matched placebo weekly

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: risedronate
• Placebo Comparator: placebo

Primary Measures

• bone mineral density of the lumbar spine
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• overall safety
  • Time Frame: 12 months
    Safety Issue?: No

Inclusion Criteria:

• Patients over 18 years of age.
• Histologically confirmed diagnosis of prostate cancer without metastases.
• Patient must have negative bone scan to rule out bone metastases.
• Patient for whom androgen deprivation therapy with leuprolide acetate is indicated for at least 1 year.
• Eastern Cooperative Oncology Group (ECOG) score of 0 - 2.
• Study medication must be started within 3 months of initiation of ADT.
• Signed written informed consent.

Exclusion Criteria:

• Prior ADT (greater than 3 months).
• History of treatment with calcitriol or bisphosphonates.
• Suppressive doses of thyroxine within the previous year.
• Concomitant or prior history of long-term treatment (greater than or equal to 3 months) with systemic glucocorticoids.
• Evidence of any of the following conditions per subject self-report or chart review:
• Current hyper- or hypothyroidism (stable on thyroid replacement therapy is allowed, if TSH is within normal reference range).
• Paget's disease, Cushing's disease, hyperprolactinemia, chronic liver disease. Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization.
• Major surgery or significant traumatic injury occurring within 1 month prior to randomization.
• Known hypersensitivity to leuprolide acetate or any of the components found in Eligard
• Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.

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: CMX Research

Overall Clinical Trial Officials and Contacts

Richard W Casey, M.D. Principal Investigator CMX Research  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00426777

Study ID Number: SA-CMX-01

ClinicalTrials.gov Identifier: NCT00426777

Health Authority: Canada: Health Canada