Status:
COMPLETED
Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer
Lead Sponsor:
CMX Research
Collaborating Sponsors:
Sanofi
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
Prostate cancer patients treated with LHRH agonists (e.g., leuprolide) lose bone mineral density. This is similar to post-menopausal osteoporosis. Risedronate is approved to prevent osteoporosis. We h...
Detailed Description
IV bisphosphonates have proven effective in treating bone loss in prostate cancer patients treated with LHRH agonists. However, it is yet to be determined if an oral bisphosphonate such as risedronate...
Eligibility Criteria
Inclusion
- Patients over 18 years of age.
- Histologically confirmed diagnosis of prostate cancer without metastases.
- Patient must have negative bone scan to rule out bone metastases.
- Patient for whom androgen deprivation therapy with leuprolide acetate is indicated for at least 1 year.
- Eastern Cooperative Oncology Group (ECOG) score of 0 - 2.
- Study medication must be started within 3 months of initiation of ADT.
- Signed written informed consent.
Exclusion
- Prior ADT (greater than 3 months).
- History of treatment with calcitriol or bisphosphonates.
- Suppressive doses of thyroxine within the previous year.
- Concomitant or prior history of long-term treatment (greater than or equal to 3 months) with systemic glucocorticoids.
- Evidence of any of the following conditions per subject self-report or chart review:
- Current hyper- or hypothyroidism (stable on thyroid replacement therapy is allowed, if TSH is within normal reference range).
- Paget's disease, Cushing's disease, hyperprolactinemia, chronic liver disease. Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization.
- Major surgery or significant traumatic injury occurring within 1 month prior to randomization.
- Known hypersensitivity to leuprolide acetate or any of the components found in Eligard
- 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 :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00426777
Start Date
January 1 2007
End Date
February 1 2009
Last Update
February 3 2012
Active Locations (21)
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1
Southern Interior Medical Research Corporation
Kelowna, British Columbia, Canada, V1Y 2H4
2
Dr. Cal Andreou
Surrey, British Columbia, Canada, V3V 1N1
3
Dr. Allan Patrick
Fredericton, New Brunswick, Canada, E3B 5B8
4
The Male/Female Health and Research Centre
Barrie, Ontario, Canada, L4M 7G1