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

February 2, 2012 updated by: CMX Research

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • Southern Interior Medical Research Corporation
      • Surrey, British Columbia, Canada, V3V 1N1
        • Dr. Cal Andreou
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 5B8
        • Dr. Allan Patrick
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • The Male/Female Health and Research Centre
      • Brampton, Ontario, Canada, L6T 3J1
        • Dr. Stanley Flax
      • Brantford, Ontario, Canada, N3R 4N3
        • Brantford Urology Research, Medical Arts Building
      • Burlington, Ontario, Canada, L7N 3V2
        • G. Kenneth Jansz Medicine Professional Corporation
      • Burlington, Ontario, Canada, L7S 1V2
        • Urology Research Centre
      • Guelph, Ontario, Canada, N1H 5J1
        • Guelph Urology Associates
      • Mississauga, Ontario, Canada, L5M 4N4
        • Credit Valley Medical Arts Centre
      • Newmarket, Ontario, Canada, L3X 1W1
        • Mor Urology Inc., Bayview Business Centre
      • Oakville, Ontario, Canada, L6H 3P1
        • The Male and Female Health Centre
      • Orillia, Ontario, Canada, L3V 7V1
        • Orillia Urology Associates
      • Oshawa, Ontario, Canada, L1H 1B9
        • Urotec
      • Owen Sound, Ontario, Canada, N4K 2J1
        • Dr. Todd Webster
      • Peterborough, Ontario, Canada, K9H 1T6
        • Kawartha Urology Associates
      • Scarborough, Ontario, Canada, M1S 4V5
        • Dr. Allan Abramovitch
      • Sudbury, Ontario, Canada, P3E 4T3
        • Northern Urology Centre
      • Toronto, Ontario, Canada, M6A 3B5
        • The Male Health Centre
      • Willowdale, Ontario, Canada, M2K 2W1
        • Dr. Roger J. Buckley
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H3
        • Urology South Shore Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Control
risedronate-matched placebo weekly
Active Comparator: risedronate
Drug: risedronate
risedronate 35mg tablet, weekly for 12 months
Other Names:
  • Actonel
Drug: risedronate
35mg weekly
Other Names:
  • Actonel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bone mineral density of the lumbar spine
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall safety
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CMX Research

Collaborators

Sanofi

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

January 24, 2007

First Submitted That Met QC Criteria

January 24, 2007

First Posted (Estimate)

January 25, 2007

Study Record Updates

Last Update Posted (Estimate)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 2, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA-CMX-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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