Bone Health Observational Study (BHOS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by CMX Research.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
CMX Research
ClinicalTrials.gov Identifier:
NCT00632905
First received: February 20, 2008
Last updated: May 30, 2011
Last verified: May 2011
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Evaluate the Incidence of Skeletal Related Events In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT).

Resource links provided by NLM:


Further study details as provided by CMX Research:

Primary Outcome Measures:
  • Bone Mineral Density of the lumbar spine [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Safety [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 2007
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinics

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632905

Locations
Canada, British Columbia
Dr. John A. Warner
Burnaby, British Columbia, Canada, V5G 1T4
Southern Interior Medical Research Corporation
Kelowna, British Columbia, Canada, V1Y 2H4
Nanaimo Urology Associates
Nanaimo, British Columbia, Canada, V9S 2B5
Central Island Research Centre
Port Alberni, British Columbia, Canada, V9Y 8C8
Andreou Research
Surrey, British Columbia, Canada, V3V 1N1
Canada, Nova Scotia
Bruce W. Palmer Urology Inc.
Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
Dr. Jonathan L. Giddens
Brampton, Ontario, Canada, L6V 1B4
Brantford Urology Research Medical Arts Bldg.
Brantford, Ontario, Canada, N3R 4N3
Dr. Richard Sowery
Burlington, Ontario, Canada, L7T 3K4
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada, L7N 3V2
Guelph Urology Associates
Guelph, Ontario, Canada, N1H 5J1
Dr. Alvaro Morales
Kingston, Ontario, Canada, K7L 3J7
GU Trials Markham
Markham, Ontario, Canada, L6B 1A1
Mor Urology Inc
Newmarket, Ontario, Canada, L3X 1W1
Medical & Dental Bldg
North Bay, Ontario, Canada, P1B 4Y3
York-Finch Med Centre
North York, Ontario, Canada, M3N 2V6
Stanley Flax Medicine Professional Corporation
North York, Ontario, Canada, M3B 3S6
The Fe/Male Health Centres
Oakville, Ontario, Canada, L6H 3P1
Orillia Urology Associates
Orillia, Ontario, Canada, L3V 7V1
Urotec
Oshawa, Ontario, Canada, L1H 1B9
Mahoney Medicine Professional Corporation
Ottawa, Ontario, Canada, K1H 8L6
2150935 Ontario Inc
Owen Sound, Ontario, Canada, N4K 2J1
Kawartha Urology Associates
Peterborough, Ontario, Canada, K9H 1T6
The Medical Centre
Peterborough, Ontario, Canada, K9J 2X5
Dr. Allan Abramovitch
Scarborough, Ontario, Canada, M1S 4V5
Dr. Peter Roney
Smiths Falls, Ontario, Canada, K7A 2H9
Northern Urology Centre
Sudbury, Ontario, Canada, P3E 4T3
West Arthur Place
Thunder Bay, Ontario, Canada, P7E 6E7
Dr. Edward Woods
Toronto, Ontario, Canada, M1P 2T7
The Male Health Centre
Toronto, Ontario, Canada, M6A 3B5
Dr. Roger Buckley
Willowdale, Ontario, Canada, M2K 2W1
ABHM Associates
Windsor, Ontario, Canada, N8Y 4X9
Canada, Quebec
Dr. Louis-Rene Barrette
Chicoutimi, Quebec, Canada, G7H 6B9
Recherches Cliniques Theradev
Granby, Quebec, Canada, J2G 8Z9
Polyclinique Med Concorde
Laval, Quebec, Canada, H7G 2E6
Ultra-Med Inc.
Point Claire, Quebec, Canada, H9R 4S3
Clinique d'Urologie du Saguenay
Saguenay, Quebec, Canada, G7H 4A3
Centre de Récherche en Urologie de Lanaudiére
St. Charles-Baromee, Quebec, Canada, J6E 6J2
Westmount Med Bldg
Westmount, Quebec, Canada, H4A 1S9
Canada, Saskatchewan
Medical Arts Bldg
Saskatoon, Saskatchewan, Canada, S7K 3H3
Sponsors and Collaborators
CMX Research
AstraZeneca
Investigators
Principal Investigator: Richard W Casey, M.D. CMX Research
  More Information

No publications provided

Responsible Party: Aaron Park/Project Manager, CMX Research
ClinicalTrials.gov Identifier: NCT00632905     History of Changes
Other Study ID Numbers: AZ-CMX-03
Study First Received: February 20, 2008
Last Updated: May 30, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by CMX Research:
Prostate Cancer
Prostatic adenoma
Prostatic neoplasm

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014