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

This study has been completed.
Sponsor:
Collaborators:
Lawson Health Research Institute Internal Review Fund
University of Western Ontario, Canada
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00199537
First received: September 13, 2005
Last updated: July 25, 2008
Last verified: July 2008
History of Changes

September 13, 2005
July 25, 2008
February 2005
February 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00199537 on ClinicalTrials.gov Archive Site
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Bone Loss in Men on Androgen Blockade as Adjuvant Therapy for Prostate Cancer
Bone Loss in Men on Androgen Blockade as Adjuvant Therapy for Prostate Cancer

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Men with Prostate Cancer undergoing continued treatment with leuteinizing hormone-releasing hormone [LHRH] therapy
  • Prostate Cancer
  • Bone Loss
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Male
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00199537
R-05-055, Lawson IRF-071-04, UWO ADF SG06-02
No
Dr. Hassan Razvi, Lawson Health Research Institute
Lawson Health Research Institute
  • Lawson Health Research Institute Internal Review Fund
  • University of Western Ontario, Canada
Principal Investigator: Hassan Razvi, MD, FRCSC Urology, St. Joseph's Hospital, University of Western Ontario
Lawson Health Research Institute
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP