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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426777
• Other study ID #: SA-CMX-01
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2007
• Last updated: February 2, 2012
• Start date: January 2007
• Est. completion date: February 2009

Study information

• Verified date: February 2012
• Source: CMX Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• risedronate
risedronate 35mg tablet, weekly for 12 months
• risedronate
35mg weekly
• Control
risedronate-matched placebo weekly

Locations

Country	Name	City	State
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	Dr. Allan Patrick	Fredericton	New Brunswick
Canada	Urology South Shore Research	Greenfield Park	Quebec
Canada	Guelph Urology Associates	Guelph	Ontario
Canada	Southern Interior Medical Research Corporation	Kelowna	British Columbia
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	Ontario
Canada	Northern Urology Centre	Sudbury	Ontario
Canada	Dr. Cal Andreou	Surrey	British Columbia
Canada	The Male Health Centre	Toronto	Ontario
Canada	Dr. Roger J. Buckley	Willowdale	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
CMX Research	Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density of the lumbar spine		12 months	No
Secondary	overall safety		12 months	No