Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer
Information source: CMX Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: risedronate (Drug); risedronate (Drug); Control (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: CMX Research Official(s) and/or principal investigator(s):
Richard W Casey, M.D., Principal Investigator, Affiliation: CMX Research
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 hypothesize that risedronate may also be effective in prostate
cancer patients treated with LHRH agonists.
Clinical Details
Official title: A Randomized, Single-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Effect of Risedronate and Placebo on Bone Mineral Density in Men Undergoing Androgen Deprivation Therapy With Leuprolide Acetate
Study design: Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: bone mineral density of the lumbar spine
Secondary outcome: overall safety
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 could offer the same benefits.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Dr. Cal Andreou, Surrey, British Columbia V3V 1N1, Canada
Southern Interior Medical Research Corporation, Kelowna, British Columbia V1Y 2H4, Canada
Dr. Allan Patrick, Fredericton, New Brunswick E3B 5B8, Canada
The Male and Female Health Centre, Oakville, Ontario L6H 3P1, Canada
Dr. Allan Abramovitch, Scarborough, Ontario M1S 4V5, Canada
The Male Health Centre, Toronto, Ontario M6A 3B5, Canada
Northern Urology Centre, Sudbury, Ontario P3E 4T3, Canada
Dr. Roger J. Buckley, Willowdale, Ontario M2K 2W1, Canada
Dr. Stanley Flax, Brampton, Ontario L6T 3J1, Canada
Guelph Urology Associates, Guelph, Ontario N1H 5J1, Canada
G. Kenneth Jansz Medicine Professional Corporation, Burlington, Ontario L7N 3V2, Canada
Brantford Urology Research, Medical Arts Building, Brantford, Ontario N3R 4N3, Canada
Mor Urology Inc., Bayview Business Centre, Newmarket, Ontario L3X 1W1, Canada
Urology Research Centre, Burlington, Ontario L7S 1V2, Canada
Urotec, Oshawa, Ontario L1H 1B9, Canada
Orillia Urology Associates, Orillia, Ontario L3V 7V1, Canada
Credit Valley Medical Arts Centre, Mississauga, Ontario L5M 4N4, Canada
Dr. Todd Webster, Owen Sound, Ontario N4K 2J1, Canada
Kawartha Urology Associates, Peterborough, Ontario K9H 1T6, Canada
The Male/Female Health and Research Centre, Barrie, Ontario L4M 7G1, Canada
Urology South Shore Research, Greenfield Park, Quebec J4V 2H3, Canada
Additional Information
Starting date: January 2007
Ending date: February 2009
Last updated: February 26, 2008
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