Bone Loss in Men on Androgen Blockade as Adjuvant Therapy for Prostate Cancer

July 25, 2008 updated by: Lawson Health Research Institute
Patients with advanced prostate cancer undergoing adjuvant treatment with androgen blockade will be followed over a 1 year interval to assess the effects of this treatment on bone metabolism. It is expected that men undergoing androgen blockade will experience accelerated bone loss.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

25

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
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men with Prostate Cancer undergoing continued treatment with leuteinizing hormone-releasing hormone [LHRH] therapy

Description

Inclusion Criteria:

  • Men
  • Age of 40 years or greater
  • Diagnosis of advanced prostate cancer (ie: prostate-specific antigen [PSA] less than 25 ug/L and undergoing continued treatment with leuteinizing hormone-releasing hormone [LHRH] therapy)
  • Willing and able to consent

Exclusion Criteria:

  • Metastatic disease to bone
  • Medications affecting bone turnover (bisphosphonate, steroids, anticonvulsant)
  • Renal failure (serum creatinine > 200 umol/L)
  • Co-morbidity factors affecting bone density (ie: Paget's, rheumatoid arthritis)
  • Factors affecting ability to perform the bone density tests using femoral head measurements (ie: bilateral hip arthroplasty)
  • Cancer other than skin, except when, in the investigators' opinion, it is determined to be appropriate and not adversely affect the outcome of the trial
  • Gastrointestinal (GI) pathology (eg. malabsorption syndrome)
  • Parathyroid disease

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

Collaborators and Investigators

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

Sponsor

Lawson Health Research Institute

Collaborators

University of Western Ontario, Canada
Lawson Health Research Institute Internal Review Fund

Investigators

  • Principal Investigator: Hassan Razvi, MD, FRCSC, Urology, St. Joseph's Hospital, University of Western Ontario

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

February 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

July 29, 2008

Last Update Submitted That Met QC Criteria

July 25, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-05-055
  • Lawson IRF-071-04
  • UWO ADF SG06-02

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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