Clinical trial NCT00632905: Bone Health Observational Study
Official title: A Prospective Study to Evaluate the Incidence of Skeletal Related Events In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Prostatic adenoma
Prostatic neoplasm
Lead sponsor: CMX Research
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2008-03-11
Enrollment: 599
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinics

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone Mineral Density of the lumbar spine
timeFrame: 12 months
Secondary outcomes:
measure: Overall Safety
timeFrame: 12 Months
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Dr. John A. Warner
state: British Columbia
city: Kelowna
country: Canada
facility: Southern Interior Medical Research Corporation
state: British Columbia
city: Nanaimo
country: Canada
facility: Nanaimo Urology Associates
state: British Columbia
city: Port Alberni
country: Canada
facility: Central Island Research Centre
state: British Columbia
city: Surrey
country: Canada
facility: Andreou Research
state: British Columbia
city: Kentville
country: Canada
facility: Bruce W. Palmer Urology Inc.
state: Nova Scotia
city: Brampton
country: Canada
facility: Dr. Jonathan L. Giddens
state: Ontario
city: Brantford
country: Canada
facility: Brantford Urology Research Medical Arts Bldg.
state: Ontario
city: Burlington
country: Canada
facility: G. Kenneth Jansz Medicine Professional Corporation
state: Ontario
city: Burlington
country: Canada
facility: Dr. Richard Sowery
state: Ontario
city: Guelph
country: Canada
facility: Guelph Urology Associates
state: Ontario
city: Kingston
country: Canada
facility: Dr. Alvaro Morales
state: Ontario
city: Markham
country: Canada
facility: GU Trials Markham
state: Ontario
city: Newmarket
country: Canada
facility: Mor Urology Inc
state: Ontario
city: North Bay
country: Canada
facility: Medical & Dental Bldg
state: Ontario
city: North York
country: Canada
facility: Stanley Flax Medicine Professional Corporation
state: Ontario
city: North York
country: Canada
facility: York-Finch Med Centre
state: Ontario
city: Oakville
country: Canada
facility: The Fe/Male Health Centres
state: Ontario
city: Orillia
country: Canada
facility: Orillia Urology Associates
state: Ontario
city: Oshawa
country: Canada
facility: Urotec
state: Ontario
city: Ottawa
country: Canada
facility: Mahoney Medicine Professional Corporation
state: Ontario
city: Owen Sound
country: Canada
facility: 2150935 Ontario Inc
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Urology Associates
state: Ontario
city: Peterborough
country: Canada
facility: The Medical Centre
state: Ontario
city: Scarborough
country: Canada
facility: Dr. Allan Abramovitch
state: Ontario
city: Smiths Falls
country: Canada
facility: Dr. Peter Roney
state: Ontario
city: Sudbury
country: Canada
facility: Northern Urology Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: West Arthur Place
state: Ontario
city: Toronto
country: Canada
facility: Dr. Edward Woods
state: Ontario
city: Toronto
country: Canada
facility: The Male Health Centre
state: Ontario
city: Willowdale
country: Canada
facility: Dr. Roger Buckley
state: Ontario
city: Windsor
country: Canada
facility: ABHM Associates
state: Ontario
city: Chicoutimi
country: Canada
facility: Dr. Louis-Rene Barrette
state: Quebec
city: Granby
country: Canada
facility: Recherches Cliniques Theradev
state: Quebec
city: Laval
country: Canada
facility: Polyclinique Med Concorde
state: Quebec
city: Point Claire
country: Canada
facility: Ultra-Med Inc.
state: Quebec
city: Saguenay
country: Canada
facility: Clinique d'Urologie du Saguenay
state: Quebec
city: St. Charles-Baromee
country: Canada
facility: Centre de Récherche en Urologie de Lanaudiére
state: Quebec
city: Westmount
country: Canada
facility: Westmount Med Bldg
state: Quebec
city: Saskatoon
country: Canada
facility: Medical Arts Bldg
state: Saskatchewan
Study officials:
affiliation: CMX Research
name: Richard W Casey, M.D.
role: PRINCIPAL_INVESTIGATOR
References: