Bone Health Observational Study (BHOS)

September 27, 2017 updated by: CMX Research

A Prospective Study to Evaluate the Incidence of Skeletal Related Events In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT).

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

599

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

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 1T4
        • Dr. John A. Warner
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • Southern Interior Medical Research Corporation
      • Nanaimo, British Columbia, Canada, V9S 2B5
        • Nanaimo Urology Associates
      • Port Alberni, British Columbia, Canada, V9Y 8C8
        • Central Island Research Centre
      • Surrey, British Columbia, Canada, V3V 1N1
        • Andreou Research
    • Nova Scotia
      • Kentville, Nova Scotia, Canada, B4N 4K9
        • Bruce W. Palmer Urology Inc.
    • Ontario
      • Brampton, Ontario, Canada, L6V 1B4
        • Dr. Jonathan L. Giddens
      • Brantford, Ontario, Canada, N3R 4N3
        • Brantford Urology Research Medical Arts Bldg.
      • Burlington, Ontario, Canada, L7N 3V2
        • G. Kenneth Jansz Medicine Professional Corporation
      • Burlington, Ontario, Canada, L7T 3K4
        • Dr. Richard Sowery
      • Guelph, Ontario, Canada, N1H 5J1
        • Guelph Urology Associates
      • Kingston, Ontario, Canada, K7L 3J7
        • Dr. Alvaro Morales
      • Markham, Ontario, Canada, L6B 1A1
        • GU Trials Markham
      • Newmarket, Ontario, Canada, L3X 1W1
        • Mor Urology Inc
      • North Bay, Ontario, Canada, P1B 4Y3
        • Medical & Dental Bldg
      • North York, Ontario, Canada, M3B 3S6
        • Stanley Flax Medicine Professional Corporation
      • North York, Ontario, Canada, M3N 2V6
        • York-Finch Med Centre
      • Oakville, Ontario, Canada, L6H 3P1
        • The Fe/Male Health Centres
      • Orillia, Ontario, Canada, L3V 7V1
        • Orillia Urology Associates
      • Oshawa, Ontario, Canada, L1H 1B9
        • Urotec
      • Ottawa, Ontario, Canada, K1H 8L6
        • Mahoney Medicine Professional Corporation
      • Owen Sound, Ontario, Canada, N4K 2J1
        • 2150935 Ontario Inc
      • Peterborough, Ontario, Canada, K9H 1T6
        • Kawartha Urology Associates
      • Peterborough, Ontario, Canada, K9J 2X5
        • The Medical Centre
      • Scarborough, Ontario, Canada, M1S 4V5
        • Dr. Allan Abramovitch
      • Smiths Falls, Ontario, Canada, K7A 2H9
        • Dr. Peter Roney
      • Sudbury, Ontario, Canada, P3E 4T3
        • Northern Urology Centre
      • Thunder Bay, Ontario, Canada, P7E 6E7
        • West Arthur Place
      • Toronto, Ontario, Canada, M1P 2T7
        • Dr. Edward Woods
      • Toronto, Ontario, Canada, M6A 3B5
        • The Male Health Centre
      • Willowdale, Ontario, Canada, M2K 2W1
        • Dr. Roger Buckley
      • Windsor, Ontario, Canada, N8Y 4X9
        • ABHM Associates
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 6B9
        • Dr. Louis-Rene Barrette
      • Granby, Quebec, Canada, J2G 8Z9
        • Recherches Cliniques Theradev
      • Laval, Quebec, Canada, H7G 2E6
        • Polyclinique Med Concorde
      • Point Claire, Quebec, Canada, H9R 4S3
        • Ultra-Med Inc.
      • Saguenay, Quebec, Canada, G7H 4A3
        • Clinique d'Urologie du Saguenay
      • St. Charles-Baromee, Quebec, Canada, J6E 6J2
        • Centre de Recherche en Urologie de Lanaudiere
      • Westmount, Quebec, Canada, H4A 1S9
        • Westmount Med Bldg
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
        • Medical Arts Bldg

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

primary care clinics

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Normal - BMD with T-score at or above -1.0
2
Osteopenic - BMD with T-score between -1.1 and -2.4
3
Osteoporotic - BMD with T-score at or below -2.5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone Mineral Density of the lumbar spine
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Safety
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CMX Research

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Richard W Casey, M.D., CMX Research

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

September 1, 2007

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

March 4, 2008

First Posted (Estimate)

March 11, 2008

Study Record Updates

Last Update Posted (Actual)

September 28, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ-CMX-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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