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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| risedronate | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risedronate | Drug | risedronate 35mg tablet, weekly for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| bone mineral density of the lumbar spine | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall safety | 12 months |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Richard W Casey, M.D. | CMX Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Interior Medical Research Corporation | Kelowna | British Columbia | V1Y 2H4 | Canada | ||
| Dr. Cal Andreou |
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| risedronate | Drug | 35mg weekly |
|
|
| Control | Drug | risedronate-matched placebo weekly |
|
| Surrey |
| British Columbia |
| V3V 1N1 |
| Canada |
| Dr. Allan Patrick | Fredericton | New Brunswick | E3B 5B8 | Canada |
| The Male/Female Health and Research Centre | Barrie | Ontario | L4M 7G1 | Canada |
| Dr. Stanley Flax | Brampton | Ontario | L6T 3J1 | Canada |
| Brantford Urology Research, Medical Arts Building | Brantford | Ontario | N3R 4N3 | Canada |
| G. Kenneth Jansz Medicine Professional Corporation | Burlington | Ontario | L7N 3V2 | Canada |
| Urology Research Centre | Burlington | Ontario | L7S 1V2 | Canada |
| Northern Urology Centre | Greater Sudbury | Ontario | P3E 4T3 | Canada |
| Guelph Urology Associates | Guelph | Ontario | N1H 5J1 | Canada |
| Credit Valley Medical Arts Centre | Mississauga | Ontario | L5M 4N4 | Canada |
| Mor Urology Inc., Bayview Business Centre | Newmarket | Ontario | L3X 1W1 | Canada |
| The Male and Female Health Centre | Oakville | Ontario | L6H 3P1 | Canada |
| Orillia Urology Associates | Orillia | Ontario | L3V 7V1 | Canada |
| Urotec | Oshawa | Ontario | L1H 1B9 | Canada |
| Dr. Todd Webster | Owen Sound | Ontario | N4K 2J1 | Canada |
| Kawartha Urology Associates | Peterborough | Ontario | K9H 1T6 | Canada |
| Dr. Allan Abramovitch | Scarborough Village | Ontario | M1S 4V5 | Canada |
| The Male Health Centre | Toronto | Ontario | M6A 3B5 | Canada |
| Dr. Roger J. Buckley | Willowdale | Ontario | M2K 2W1 | Canada |
| Urology South Shore Research | Greenfield Park | Quebec | J4V 2H3 | Canada |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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