Bone Health Observational Study

Prostate Cancer Clinical Trial

— BHOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632905
• Other study ID #: AZ-CMX-03
• Status: Completed
• Phase: N/A
• First received: February 20, 2008
• Last updated: September 27, 2017
• Start date: September 2007
• Est. completion date: March 2016

Study information

• Verified date: September 2017
• Source: CMX Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 599
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Canada	Dr. Jonathan L. Giddens	Brampton	Ontario
Canada	Brantford Urology Research Medical Arts Bldg.	Brantford	Ontario
Canada	Dr. Richard Sowery	Burlington	Ontario
Canada	G. Kenneth Jansz Medicine Professional Corporation	Burlington	Ontario
Canada	Dr. John A. Warner	Burnaby	British Columbia
Canada	Dr. Louis-Rene Barrette	Chicoutimi	Quebec
Canada	Recherches Cliniques Theradev	Granby	Quebec
Canada	Guelph Urology Associates	Guelph	Ontario
Canada	Southern Interior Medical Research Corporation	Kelowna	British Columbia
Canada	Bruce W. Palmer Urology Inc.	Kentville	Nova Scotia
Canada	Dr. Alvaro Morales	Kingston	Ontario
Canada	Polyclinique Med Concorde	Laval	Quebec
Canada	GU Trials Markham	Markham	Ontario
Canada	Nanaimo Urology Associates	Nanaimo	British Columbia
Canada	Mor Urology Inc	Newmarket	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	Urotec	Oshawa	Ontario
Canada	Mahoney Medicine Professional Corporation	Ottawa	Ontario
Canada	2150935 Ontario Inc	Owen Sound	Ontario
Canada	Kawartha Urology Associates	Peterborough	Ontario
Canada	The Medical Centre	Peterborough	Ontario
Canada	Ultra-Med Inc.	Point Claire	Quebec
Canada	Central Island Research Centre	Port Alberni	British Columbia
Canada	Clinique d'Urologie du Saguenay	Saguenay	Quebec
Canada	Medical Arts Bldg	Saskatoon	Saskatchewan
Canada	Dr. Allan Abramovitch	Scarborough	Ontario
Canada	Dr. Peter Roney	Smiths Falls	Ontario
Canada	Centre de Récherche en Urologie de Lanaudiére	St. Charles-Baromee	Quebec
Canada	Northern Urology Centre	Sudbury	Ontario
Canada	Andreou Research	Surrey	British Columbia
Canada	West Arthur Place	Thunder Bay	Ontario
Canada	Dr. Edward Woods	Toronto	Ontario
Canada	The Male Health Centre	Toronto	Ontario
Canada	Westmount Med Bldg	Westmount	Quebec
Canada	Dr. Roger Buckley	Willowdale	Ontario
Canada	ABHM Associates	Windsor	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
CMX Research	AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density of the lumbar spine		12 months
Secondary	Overall Safety		12 Months