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Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer

Information source: CMX Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: risedronate (Drug); risedronate (Drug); Control (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: CMX Research

Official(s) and/or principal investigator(s):
Richard W Casey, M.D., Principal Investigator, Affiliation: CMX Research

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.

Clinical Details

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

Study design: Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: bone mineral density of the lumbar spine

Secondary outcome: overall safety

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Locations and Contacts

Dr. Cal Andreou, Surrey, British Columbia V3V 1N1, Canada

Southern Interior Medical Research Corporation, Kelowna, British Columbia V1Y 2H4, Canada

Dr. Allan Patrick, Fredericton, New Brunswick E3B 5B8, Canada

The Male and Female Health Centre, Oakville, Ontario L6H 3P1, Canada

Dr. Allan Abramovitch, Scarborough, Ontario M1S 4V5, Canada

The Male Health Centre, Toronto, Ontario M6A 3B5, Canada

Northern Urology Centre, Sudbury, Ontario P3E 4T3, Canada

Dr. Roger J. Buckley, Willowdale, Ontario M2K 2W1, Canada

Dr. Stanley Flax, Brampton, Ontario L6T 3J1, Canada

Guelph Urology Associates, Guelph, Ontario N1H 5J1, Canada

G. Kenneth Jansz Medicine Professional Corporation, Burlington, Ontario L7N 3V2, Canada

Brantford Urology Research, Medical Arts Building, Brantford, Ontario N3R 4N3, Canada

Mor Urology Inc., Bayview Business Centre, Newmarket, Ontario L3X 1W1, Canada

Urology Research Centre, Burlington, Ontario L7S 1V2, Canada

Urotec, Oshawa, Ontario L1H 1B9, Canada

Orillia Urology Associates, Orillia, Ontario L3V 7V1, Canada

Credit Valley Medical Arts Centre, Mississauga, Ontario L5M 4N4, Canada

Dr. Todd Webster, Owen Sound, Ontario N4K 2J1, Canada

Kawartha Urology Associates, Peterborough, Ontario K9H 1T6, Canada

The Male/Female Health and Research Centre, Barrie, Ontario L4M 7G1, Canada

Urology South Shore Research, Greenfield Park, Quebec J4V 2H3, Canada

Additional Information

Starting date: January 2007
Ending date: February 2009
Last updated: February 26, 2008

Page last updated: June 20, 2008

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