Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer
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
1 other identifier
interventional
160
1 country
21
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 hypothesize that risedronate may also be effective in prostate cancer patients treated with LHRH agonists.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 prostate-cancer
Started Jan 2007
Shorter than P25 for phase_3 prostate-cancer
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 24, 2007
CompletedFirst Posted
Study publicly available on registry
January 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFebruary 3, 2012
February 1, 2012
2 years
January 24, 2007
February 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bone mineral density of the lumbar spine
12 months
Secondary Outcomes (1)
overall safety
12 months
Study Arms (2)
risedronate
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CMX Researchlead
- Sanoficollaborator
Study Sites (21)
Southern Interior Medical Research Corporation
Kelowna, British Columbia, V1Y 2H4, Canada
Dr. Cal Andreou
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard W Casey, M.D.
CMX Research
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2007
First Posted
January 25, 2007
Study Start
January 1, 2007
Primary Completion
January 1, 2009
Study Completion
February 1, 2009
Last Updated
February 3, 2012
Record last verified: 2012-02