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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
  Purpose

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
Prostate Cancer
Bone Loss

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Loss in Men on Androgen Blockade as Adjuvant Therapy for Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Enrollment: 25
Study Start Date: February 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199537

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: Dr. Hassan Razvi, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00199537     History of Changes
Other Study ID Numbers: R-05-055, Lawson IRF-071-04, UWO ADF SG06-02
Study First Received: September 13, 2005
Last Updated: July 25, 2008
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013