Status:
COMPLETED
Bone Health Observational Study
Lead Sponsor:
CMX Research
Collaborating Sponsors:
AstraZeneca
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
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...
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. M...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT00632905
Start Date
September 1 2007
End Date
March 1 2016
Last Update
September 28 2017
Active Locations (40)
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1
Dr. John A. Warner
Burnaby, British Columbia, Canada, V5G 1T4
2
Southern Interior Medical Research Corporation
Kelowna, British Columbia, Canada, V1Y 2H4
3
Nanaimo Urology Associates
Nanaimo, British Columbia, Canada, V9S 2B5
4
Central Island Research Centre
Port Alberni, British Columbia, Canada, V9Y 8C8