Bone Health Observational Study

NCT ID: NCT00632905

Last Updated: 2017-09-28

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

599 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2016-03-31

Brief Summary

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Prostate Cancer patients treated with LHRH agonists (e.g., goserelin) lose Bone Mineral Density (BMD). Using a prospective, observational study design, we propose that monitoring how physicians manage Cancer Treatment Induced Bone Loss(CTIBL) in their patients. The gold standard for evaluating BMD is dual energy x-ray absorptiometry (DEXA). The proposed study will provide some of the first prospective data on the rates of Skeletal Related Events (SREs) in prostate cancer patients undergoing ADT and help develop official guidelines on the use of DEXA screening for prostate cancer patients.

Detailed Description

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A consequence of ADT is the gradual bone loss, so-called cancer treatment induced bone loss (CTIBL). The current standard of care is the addition of Vitamin D and Calcium upon the initiation of ADT. Moreover, bisphosphonates are now being considered to treat and prevent CTIBL. However, bisphosphonates are costly, thus there is a desire to identify or target a specific subset of patients who would most benefit from the treatment.

By obtaining baseline BMD and monitoring for Skeletal Related Events (SREs), we hope to identify that specific sub-set of patients who would most benefit from the treatment. Using a prospective, observational study design, we propose monitoring how physicians manage CTIBL in their patients.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Normal - BMD with T-score at or above -1.0

No interventions assigned to this group

2

Osteopenic - BMD with T-score between -1.1 and -2.4

No interventions assigned to this group

3

Osteoporotic - BMD with T-score at or below -2.5

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients willing to provide written Informed Consent.
* Patients for whom Androgen Deprivation Therapy (ADT) with Zoladex® is indicated for at least 1 year.
* Patients started on Zoladex® within the last 4 months.

Exclusion Criteria

* Patient had surgery or significant traumatic injury occurring within 1 month prior to consent.
* Known hypersensitivity to Goserelin Acetate or any of the components found in Zoladex®.
* Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

CMX Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard W Casey, M.D.

Role: PRINCIPAL_INVESTIGATOR

CMX Research

Locations

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The Male Health Centre

Toronto, Ontario, Canada

Site Status

Dr. Roger Buckley

Willowdale, Ontario, Canada

Site Status

ABHM Associates

Windsor, Ontario, Canada

Site Status

Dr. Louis-Rene Barrette

Chicoutimi, Quebec, Canada

Site Status

Recherches Cliniques Theradev

Granby, Quebec, Canada

Site Status

Polyclinique Med Concorde

Laval, Quebec, Canada

Site Status

Ultra-Med Inc.

Point Claire, Quebec, Canada

Site Status

Clinique d'Urologie du Saguenay

Saguenay, Quebec, Canada

Site Status

Dr. John A. Warner

Burnaby, British Columbia, Canada

Site Status

Southern Interior Medical Research Corporation

Kelowna, British Columbia, Canada

Site Status

Nanaimo Urology Associates

Nanaimo, British Columbia, Canada

Site Status

Central Island Research Centre

Port Alberni, British Columbia, Canada

Site Status

Andreou Research

Surrey, British Columbia, Canada

Site Status

Bruce W. Palmer Urology Inc.

Kentville, Nova Scotia, Canada

Site Status

Dr. Jonathan L. Giddens

Brampton, Ontario, Canada

Site Status

Brantford Urology Research Medical Arts Bldg.

Brantford, Ontario, Canada

Site Status

G. Kenneth Jansz Medicine Professional Corporation

Burlington, Ontario, Canada

Site Status

Dr. Richard Sowery

Burlington, Ontario, Canada

Site Status

Northern Urology Centre

Greater Sudbury, Ontario, Canada

Site Status

Guelph Urology Associates

Guelph, Ontario, Canada

Site Status

Dr. Alvaro Morales

Kingston, Ontario, Canada

Site Status

GU Trials Markham

Markham, Ontario, Canada

Site Status

Mor Urology Inc

Newmarket, Ontario, Canada

Site Status

Medical & Dental Bldg

North Bay, Ontario, Canada

Site Status

Stanley Flax Medicine Professional Corporation

North York, Ontario, Canada

Site Status

York-Finch Med Centre

North York, Ontario, Canada

Site Status

The Fe/Male Health Centres

Oakville, Ontario, Canada

Site Status

Orillia Urology Associates

Orillia, Ontario, Canada

Site Status

Urotec

Oshawa, Ontario, Canada

Site Status

Mahoney Medicine Professional Corporation

Ottawa, Ontario, Canada

Site Status

2150935 Ontario Inc

Owen Sound, Ontario, Canada

Site Status

Kawartha Urology Associates

Peterborough, Ontario, Canada

Site Status

The Medical Centre

Peterborough, Ontario, Canada

Site Status

Dr. Allan Abramovitch

Scarborough Village, Ontario, Canada

Site Status

Dr. Peter Roney

Smiths Falls, Ontario, Canada

Site Status

West Arthur Place

Thunder Bay, Ontario, Canada

Site Status

Dr. Edward Woods

Toronto, Ontario, Canada

Site Status

Centre de Récherche en Urologie de Lanaudiére

Saint Charles-Baromee, Quebec, Canada

Site Status

Westmount Med Bldg

Westmount, Quebec, Canada

Site Status

Medical Arts Bldg

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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AZ-CMX-03

Identifier Type: -

Identifier Source: org_study_id