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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199537
• Other study ID #: R-05-055
• Secondary ID: Lawson IRF-071-0
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: July 25, 2008
• Start date: February 2005
• Est. completion date: February 2008

Study information

• Verified date: July 2008
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Loss
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Canada	Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Lawson Health Research Institute Internal Review Fund, University of Western Ontario, Canada

Country where clinical trial is conducted

Canada,