Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer
- Registration Number
- NCT00426777
- Lead Sponsor
- CMX Research
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 160
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Control - risedronate risedronate -
- Primary Outcome Measures
Name Time Method bone mineral density of the lumbar spine 12 months
- Secondary Outcome Measures
Name Time Method overall safety 12 months
Trial Locations
- Locations (21)
Dr. Cal Andreou
🇨🇦Surrey, British Columbia, Canada
Dr. Allan Patrick
🇨🇦Fredericton, New Brunswick, Canada
Urology South Shore Research
🇨🇦Greenfield Park, Quebec, Canada
Credit Valley Medical Arts Centre
🇨🇦Mississauga, Ontario, Canada
Southern Interior Medical Research Corporation
🇨🇦Kelowna, British Columbia, Canada
Dr. Stanley Flax
🇨🇦Brampton, Ontario, Canada
Urotec
🇨🇦Oshawa, Ontario, Canada
Brantford Urology Research, Medical Arts Building
🇨🇦Brantford, Ontario, Canada
The Male Health Centre
🇨🇦Toronto, Ontario, Canada
The Male/Female Health and Research Centre
🇨🇦Barrie, Ontario, Canada
Urology Research Centre
🇨🇦Burlington, Ontario, Canada
G. Kenneth Jansz Medicine Professional Corporation
🇨🇦Burlington, Ontario, Canada
Guelph Urology Associates
🇨🇦Guelph, Ontario, Canada
The Male and Female Health Centre
🇨🇦Oakville, Ontario, Canada
Mor Urology Inc., Bayview Business Centre
🇨🇦Newmarket, Ontario, Canada
Dr. Todd Webster
🇨🇦Owen Sound, Ontario, Canada
Northern Urology Centre
🇨🇦Sudbury, Ontario, Canada
Kawartha Urology Associates
🇨🇦Peterborough, Ontario, Canada
Dr. Allan Abramovitch
🇨🇦Scarborough, Ontario, Canada
Dr. Roger J. Buckley
🇨🇦Willowdale, Ontario, Canada
Orillia Urology Associates
🇨🇦Orillia, Ontario, Canada