Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer
NCT ID: NCT00426777
Last Updated: 2012-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
160 participants
INTERVENTIONAL
2007-01-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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risedronate
risedronate
risedronate 35mg tablet, weekly for 12 months
risedronate
35mg weekly
placebo
Control
risedronate-matched placebo weekly
Interventions
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risedronate
risedronate 35mg tablet, weekly for 12 months
risedronate
35mg weekly
Control
risedronate-matched placebo weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
CMX Research
OTHER
Responsible Party
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Principal Investigators
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Richard W Casey, M.D.
Role: PRINCIPAL_INVESTIGATOR
CMX Research
Locations
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Southern Interior Medical Research Corporation
Kelowna, British Columbia, Canada
Dr. Cal Andreou
Surrey, British Columbia, Canada
Dr. Allan Patrick
Fredericton, New Brunswick, Canada
The Male/Female Health and Research Centre
Barrie, Ontario, Canada
Dr. Stanley Flax
Brampton, Ontario, Canada
Brantford Urology Research, Medical Arts Building
Brantford, Ontario, Canada
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada
Urology Research Centre
Burlington, Ontario, Canada
Northern Urology Centre
Greater Sudbury, Ontario, Canada
Guelph Urology Associates
Guelph, Ontario, Canada
Credit Valley Medical Arts Centre
Mississauga, Ontario, Canada
Mor Urology Inc., Bayview Business Centre
Newmarket, Ontario, Canada
The Male and Female Health Centre
Oakville, Ontario, Canada
Orillia Urology Associates
Orillia, Ontario, Canada
Urotec
Oshawa, Ontario, Canada
Dr. Todd Webster
Owen Sound, Ontario, Canada
Kawartha Urology Associates
Peterborough, Ontario, Canada
Dr. Allan Abramovitch
Scarborough Village, Ontario, Canada
The Male Health Centre
Toronto, Ontario, Canada
Dr. Roger J. Buckley
Willowdale, Ontario, Canada
Urology South Shore Research
Greenfield Park, Quebec, Canada
Countries
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Other Identifiers
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SA-CMX-01
Identifier Type: -
Identifier Source: org_study_id
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