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Bone Health Observational Study (BHOS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00632905
First Posted: March 11, 2008
Last Update Posted: December 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
CMX Research
February 20, 2008
March 11, 2008
December 22, 2016
September 2007
March 2016   (Final data collection date for primary outcome measure)
Bone Mineral Density of the lumbar spine [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT00632905 on ClinicalTrials.gov Archive Site
Overall Safety [ Time Frame: 12 Months ]
Same as current
Not Provided
Not Provided
 
Bone Health Observational Study
A Prospective Study to Evaluate the Incidence of Skeletal Related Events In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT).
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
primary care clinics
Prostate Cancer
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
599
March 2016
March 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00632905
AZ-CMX-03
No
Not Provided
Plan to Share IPD: Undecided
CMX Research
CMX Research
AstraZeneca
Principal Investigator: Richard W Casey, M.D. CMX Research
CMX Research
December 2016
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