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Sponsors and Collaborators: |
CMX Research Sanofi-Aventis |
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Information provided by: | CMX Research |
ClinicalTrials.gov Identifier: | NCT00426777 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: risedronate Drug: Control |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 160 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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risedronate: Active Comparator |
Drug: risedronate
risedronate 35mg tablet, weekly for 12 months
Drug: risedronate
35mg weekly
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placebo: Placebo Comparator |
Drug: Control
risedronate-matched placebo weekly
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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.
Canada, British Columbia | |
Dr. Cal Andreou | |
Surrey, British Columbia, Canada, V3V 1N1 | |
Southern Interior Medical Research Corporation | |
Kelowna, British Columbia, Canada, V1Y 2H4 | |
Canada, New Brunswick | |
Dr. Allan Patrick | |
Fredericton, New Brunswick, Canada, E3B 5B8 | |
Canada, Ontario | |
The Male and Female Health Centre | |
Oakville, Ontario, Canada, L6H 3P1 | |
Dr. Allan Abramovitch | |
Scarborough, Ontario, Canada, M1S 4V5 | |
Guelph Urology Associates | |
Guelph, Ontario, Canada, N1H 5J1 | |
Northern Urology Centre | |
Sudbury, Ontario, Canada, P3E 4T3 | |
Dr. Roger J. Buckley | |
Willowdale, Ontario, Canada, M2K 2W1 | |
Dr. Stanley Flax | |
Brampton, Ontario, Canada, L6T 3J1 | |
The Male Health Centre | |
Toronto, Ontario, Canada, M6A 3B5 | |
G. Kenneth Jansz Medicine Professional Corporation | |
Burlington, Ontario, Canada, L7N 3V2 | |
Brantford Urology Research, Medical Arts Building | |
Brantford, Ontario, Canada, N3R 4N3 | |
Mor Urology Inc., Bayview Business Centre | |
Newmarket, Ontario, Canada, L3X 1W1 | |
Urology Research Centre | |
Burlington, Ontario, Canada, L7S 1V2 | |
Urotec | |
Oshawa, Ontario, Canada, L1H 1B9 | |
Orillia Urology Associates | |
Orillia, Ontario, Canada, L3V 7V1 | |
Credit Valley Medical Arts Centre | |
Mississauga, Ontario, Canada, L5M 4N4 | |
Dr. Todd Webster | |
Owen Sound, Ontario, Canada, N4K 2J1 | |
Kawartha Urology Associates | |
Peterborough, Ontario, Canada, K9H 1T6 | |
The Male/Female Health and Research Centre | |
Barrie, Ontario, Canada, L4M 7G1 | |
Canada, Quebec | |
Urology South Shore Research | |
Greenfield Park, Quebec, Canada, J4V 2H3 |
Principal Investigator: | Richard W Casey, M.D. | CMX Research |
Responsible Party: | CMX Research ( Carlo Mendoza, VP Contract Research Services ) |
Study ID Numbers: | SA-CMX-01 |
Study First Received: | January 24, 2007 |
Last Updated: | February 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00426777 |
Health Authority: | Canada: Health Canada |
prostate cancer prostatic adenoma prostatic neoplasm |
Calcium, Dietary Prostatic Diseases Genital Neoplasms, Male Leuprolide Urogenital Neoplasms |
Genital Diseases, Male Adenoma Prostatic Neoplasms Risedronic acid |
Membrane Transport Modulators Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Calcium Channel Blockers Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions |