Clincosm LogoSign in Get a demo

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

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00199537
Collaborator
Lawson Health Research Institute Internal Review Fund (Other), University of Western Ontario, Canada (Other)
25
Enrollment
1
Location
36
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    25 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Bone Loss in Men on Androgen Blockade as Adjuvant Therapy for Prostate Cancer
    Study Start Date :
    Feb 1, 2005
    Actual Primary Completion Date :
    Feb 1, 2008
    Actual Study Completion Date :
    Feb 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      40 Years and Older
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London London Ontario Canada N6A 4V2

      Sponsors and Collaborators

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

      Investigators

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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00199537
      Other Study ID Numbers:
      • R-05-055
      • Lawson IRF-071-04
      • UWO ADF SG06-02
      First Posted:
      Sep 20, 2005
      Last Update Posted:
      Jul 29, 2008
      Last Verified:
      Jul 1, 2008
      Additional relevant MeSH terms:
      Prostatic Neoplasms

      Study Results

      No Results Posted as of Jul 29, 2008