Bone Health Observational Study
BHOS
A Prospective Study to Evaluate the Incidence of Skeletal Related Events In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT).
1 other identifier
observational
599
1 country
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2007
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 20, 2008
CompletedFirst Posted
Study publicly available on registry
March 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedSeptember 28, 2017
September 1, 2017
8.5 years
February 20, 2008
September 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone Mineral Density of the lumbar spine
12 months
Secondary Outcomes (1)
Overall Safety
12 Months
Study Arms (3)
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
Eligibility Criteria
primary care clinics
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CMX Researchlead
- AstraZenecacollaborator
Study Sites (40)
Dr. John A. Warner
Burnaby, British Columbia, V5G 1T4, Canada
Southern Interior Medical Research Corporation
Kelowna, British Columbia, V1Y 2H4, Canada
Nanaimo Urology Associates
Nanaimo, British Columbia, V9S 2B5, Canada
Central Island Research Centre
Port Alberni, British Columbia, V9Y 8C8, Canada
Andreou Research
Surrey, British Columbia, V3V 1N1, Canada
Bruce W. Palmer Urology Inc.
Kentville, Nova Scotia, B4N 4K9, Canada
Dr. Jonathan L. Giddens
Brampton, Ontario, L6V 1B4, Canada
Brantford Urology Research Medical Arts Bldg.
Brantford, Ontario, N3R 4N3, Canada
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, L7N 3V2, Canada
Dr. Richard Sowery
Burlington, Ontario, L7T 3K4, Canada
Northern Urology Centre
Greater Sudbury, Ontario, P3E 4T3, Canada
Guelph Urology Associates
Guelph, Ontario, N1H 5J1, Canada
Dr. Alvaro Morales
Kingston, Ontario, K7L 3J7, Canada
GU Trials Markham
Markham, Ontario, L6B 1A1, Canada
Mor Urology Inc
Newmarket, Ontario, L3X 1W1, Canada
Medical & Dental Bldg
North Bay, Ontario, P1B 4Y3, Canada
Stanley Flax Medicine Professional Corporation
North York, Ontario, M3B 3S6, Canada
York-Finch Med Centre
North York, Ontario, M3N 2V6, Canada
The Fe/Male Health Centres
Oakville, Ontario, L6H 3P1, Canada
Orillia Urology Associates
Orillia, Ontario, L3V 7V1, Canada
Urotec
Oshawa, Ontario, L1H 1B9, Canada
Mahoney Medicine Professional Corporation
Ottawa, Ontario, K1H 8L6, Canada
2150935 Ontario Inc
Owen Sound, Ontario, N4K 2J1, Canada
Kawartha Urology Associates
Peterborough, Ontario, K9H 1T6, Canada
The Medical Centre
Peterborough, Ontario, K9J 2X5, Canada
Dr. Allan Abramovitch
Scarborough Village, Ontario, M1S 4V5, Canada
Dr. Peter Roney
Smiths Falls, Ontario, K7A 2H9, Canada
West Arthur Place
Thunder Bay, Ontario, P7E 6E7, Canada
Dr. Edward Woods
Toronto, Ontario, M1P 2T7, Canada
The Male Health Centre
Toronto, Ontario, M6A 3B5, Canada
Dr. Roger Buckley
Willowdale, Ontario, M2K 2W1, Canada
ABHM Associates
Windsor, Ontario, N8Y 4X9, Canada
Dr. Louis-Rene Barrette
Chicoutimi, Quebec, G7H 6B9, Canada
Recherches Cliniques Theradev
Granby, Quebec, J2G 8Z9, Canada
Polyclinique Med Concorde
Laval, Quebec, H7G 2E6, Canada
Ultra-Med Inc.
Point Claire, Quebec, H9R 4S3, Canada
Clinique d'Urologie du Saguenay
Saguenay, Quebec, G7H 4A3, Canada
Centre de Récherche en Urologie de Lanaudiére
Saint Charles-Baromee, Quebec, J6E 6J2, Canada
Westmount Med Bldg
Westmount, Quebec, H4A 1S9, Canada
Medical Arts Bldg
Saskatoon, Saskatchewan, S7K 3H3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard W Casey, M.D.
CMX Research
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2008
First Posted
March 11, 2008
Study Start
September 1, 2007
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
September 28, 2017
Record last verified: 2017-09