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