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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00199537
First Posted: September 20, 2005
Last Update Posted: July 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Lawson Health Research Institute Internal Review Fund
University of Western Ontario, Canada
Information provided by:
Lawson Health Research Institute
September 13, 2005
September 20, 2005
July 29, 2008
February 2005
February 2008   (Final data collection date for primary outcome measure)
Not Provided
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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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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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
Not Provided
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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
Sexes Eligible for Study: Male
40 Years and older   (Adult, Senior)
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
Not Provided
Not Provided
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