Bone Health Observational Study
- Conditions
- Prostate Cancer
- Registration Number
- NCT00632905
- Lead Sponsor
- CMX Research
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 599
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone Mineral Density of the lumbar spine 12 months
- Secondary Outcome Measures
Name Time Method Overall Safety 12 Months
Trial Locations
- Locations (40)
Mor Urology Inc
🇨🇦Newmarket, Ontario, Canada
Urotec
🇨🇦Oshawa, Ontario, Canada
Dr. Jonathan L. Giddens
🇨🇦Brampton, Ontario, Canada
Brantford Urology Research Medical Arts Bldg.
🇨🇦Brantford, Ontario, Canada
Dr. Richard Sowery
🇨🇦Burlington, Ontario, Canada
Guelph Urology Associates
🇨🇦Guelph, Ontario, Canada
Dr. Alvaro Morales
🇨🇦Kingston, Ontario, Canada
GU Trials Markham
🇨🇦Markham, Ontario, Canada
Medical & Dental Bldg
🇨🇦North Bay, Ontario, Canada
Stanley Flax Medicine Professional Corporation
🇨🇦North York, Ontario, Canada
York-Finch Med Centre
🇨🇦North York, Ontario, Canada
The Fe/Male Health Centres
🇨🇦Oakville, Ontario, Canada
Orillia Urology Associates
🇨🇦Orillia, Ontario, Canada
Mahoney Medicine Professional Corporation
🇨🇦Ottawa, Ontario, Canada
2150935 Ontario Inc
🇨🇦Owen Sound, Ontario, Canada
Kawartha Urology Associates
🇨🇦Peterborough, Ontario, Canada
Dr. Allan Abramovitch
🇨🇦Scarborough, Ontario, Canada
Dr. Peter Roney
🇨🇦Smiths Falls, Ontario, Canada
The Medical Centre
🇨🇦Peterborough, Ontario, Canada
West Arthur Place
🇨🇦Thunder Bay, Ontario, Canada
Northern Urology Centre
🇨🇦Sudbury, Ontario, Canada
Dr. Edward Woods
🇨🇦Toronto, Ontario, Canada
The Male Health Centre
🇨🇦Toronto, Ontario, Canada
ABHM Associates
🇨🇦Windsor, Ontario, Canada
Dr. Louis-Rene Barrette
🇨🇦Chicoutimi, Quebec, Canada
Dr. Roger Buckley
🇨🇦Willowdale, Ontario, Canada
Centre de Récherche en Urologie de Lanaudiére
🇨🇦St. Charles-Baromee, Quebec, Canada
Medical Arts Bldg
🇨🇦Saskatoon, Saskatchewan, Canada
G. Kenneth Jansz Medicine Professional Corporation
🇨🇦Burlington, Ontario, Canada
Southern Interior Medical Research Corporation
🇨🇦Kelowna, British Columbia, Canada
Recherches Cliniques Theradev
🇨🇦Granby, Quebec, Canada
Bruce W. Palmer Urology Inc.
🇨🇦Kentville, Nova Scotia, Canada
Westmount Med Bldg
🇨🇦Westmount, Quebec, Canada
Polyclinique Med Concorde
🇨🇦Laval, Quebec, Canada
Ultra-Med Inc.
🇨🇦Point Claire, Quebec, Canada
Dr. John A. Warner
🇨🇦Burnaby, British Columbia, Canada
Central Island Research Centre
🇨🇦Port Alberni, British Columbia, Canada
Andreou Research
🇨🇦Surrey, British Columbia, Canada
Clinique d'Urologie du Saguenay
🇨🇦Saguenay, Quebec, Canada
Nanaimo Urology Associates
🇨🇦Nanaimo, British Columbia, Canada