Bone Health Observational Study

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00632905
• Lead Sponsor: CMX Research

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-03-04
• Study First Posted: 2008-03-11
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 599

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density of the lumbar spine	12 months

Secondary Outcome Measures

Name	Time	Method
Overall Safety	12 Months

Trial Locations

Locations (40)

Dr. John A. Warner; 🇨🇦 Burnaby, British Columbia, Canada

Southern Interior Medical Research Corporation; 🇨🇦 Kelowna, British Columbia, Canada

Nanaimo Urology Associates; 🇨🇦 Nanaimo, British Columbia, Canada

Central Island Research Centre; 🇨🇦 Port Alberni, British Columbia, Canada

Andreou Research; 🇨🇦 Surrey, British Columbia, Canada

Bruce W. Palmer Urology Inc.; 🇨🇦 Kentville, Nova Scotia, Canada

Dr. Jonathan L. Giddens; 🇨🇦 Brampton, Ontario, Canada

Brantford Urology Research Medical Arts Bldg.; 🇨🇦 Brantford, Ontario, Canada

G. Kenneth Jansz Medicine Professional Corporation; 🇨🇦 Burlington, Ontario, Canada

Dr. Richard Sowery; 🇨🇦 Burlington, Ontario, Canada

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