Bone Health Observational Study
This trial has been completed.
|Start date||September 2007|
|End date||March 2016|
|Trial size||599 participants|
|Trial identifier||NCT00632905, AZ-CMX-03|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Burnaby, Canada||Dr. John A. Warner||completed|
|Kelowna, Canada||Southern Interior Medical Research Corporation||completed|
|Nanaimo, Canada||Nanaimo Urology Associates||completed|
|Port Alberni, Canada||Central Island Research Centre||completed|
|Surrey, Canada||Andreou Research||completed|
|Kentville, Canada||Bruce W. Palmer Urology Inc.||completed|
|Brampton, Canada||Dr. Jonathan L. Giddens||completed|
|Brantford, Canada||Brantford Urology Research Medical Arts Bldg.||completed|
|Burlington, Canada||G. Kenneth Jansz Medicine Professional Corporation||completed|
|Burlington, Canada||Dr. Richard Sowery||completed|
|Guelph, Canada||Guelph Urology Associates||completed|
|Kingston, Canada||Dr. Alvaro Morales||completed|
|Markham, Canada||GU Trials Markham||completed|
|Newmarket, Canada||Mor Urology Inc||completed|
|North Bay, Canada||Medical & Dental Bldg||completed|
|North York, Canada||Stanley Flax Medicine Professional Corporation||completed|
|North York, Canada||York-Finch Med Centre||completed|
|Oakville, Canada||The Fe/Male Health Centres||completed|
|Orillia, Canada||Orillia Urology Associates||completed|
|Ottawa, Canada||Mahoney Medicine Professional Corporation||completed|
|Owen Sound, Canada||2150935 Ontario Inc||completed|
|Peterborough, Canada||Kawartha Urology Associates||completed|
|Peterborough, Canada||The Medical Centre||completed|
|Scarborough, Canada||Dr. Allan Abramovitch||completed|
|Smiths Falls, Canada||Dr. Peter Roney||completed|
|Sudbury, Canada||Northern Urology Centre||completed|
|Thunder Bay, Canada||West Arthur Place||completed|
|Toronto, Canada||Dr. Edward Woods||completed|
|Toronto, Canada||The Male Health Centre||completed|
|Willowdale, Canada||Dr. Roger Buckley||completed|
|Windsor, Canada||ABHM Associates||completed|
|Chicoutimi, Canada||Dr. Louis-Rene Barrette||completed|
|Granby, Canada||Recherches Cliniques Theradev||completed|
|Laval, Canada||Polyclinique Med Concorde||completed|
|Point Claire, Canada||Ultra-Med Inc.||completed|
|Saguenay, Canada||Clinique d'Urologie du Saguenay||completed|
|St. Charles-Baromee, Canada||Centre de Récherche en Urologie de Lanaudiére||completed|
|Westmount, Canada||Westmount Med Bldg||completed|
|Saskatoon, Canada||Medical Arts Bldg||completed|
Normal - BMD with T-score at or above -1.0
Osteopenic - BMD with T-score between -1.1 and -2.4
Osteoporotic - BMD with T-score at or below -2.5
Bone Mineral Density of the lumbar spine
time frame: 12 months
time frame: 12 Months
Male participants at least 18 years old.
- 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.
|Official title||A Prospective Study to Evaluate the Incidence of Skeletal Related Events In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT).|
|Principal investigator||Richard W Casey, M.D.|
|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.|
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