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

NCT ID: NCT00199537

Last Updated: 2008-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Bone Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Lawson Health Research Institute Internal Review Fund

UNKNOWN

Sponsor Role collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Lawson Health Research Institute

Principal Investigators

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Hassan Razvi, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Urology, St. Joseph's Hospital, University of Western Ontario

Locations

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Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Lawson IRF-071-04

Identifier Type: -

Identifier Source: secondary_id

UWO ADF SG06-02

Identifier Type: -

Identifier Source: secondary_id

R-05-055

Identifier Type: -

Identifier Source: org_study_id

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