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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
CMX Research
ClinicalTrials.gov Identifier:
NCT00426777
First received: January 24, 2007
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: risedronate
Drug: Control
Phase 3

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

Resource links provided by NLM:


Further study details as provided by CMX Research:

Primary Outcome Measures:
  • bone mineral density of the lumbar spine [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall safety [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: January 2007
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: risedronate Drug: risedronate
risedronate 35mg tablet, weekly for 12 months
Other Name: Actonel
Drug: risedronate
35mg weekly
Other Name: Actonel
Placebo Comparator: placebo Drug: Control
risedronate-matched placebo weekly

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426777

Locations
Canada, British Columbia
Southern Interior Medical Research Corporation
Kelowna, British Columbia, Canada, V1Y 2H4
Dr. Cal Andreou
Surrey, British Columbia, Canada, V3V 1N1
Canada, New Brunswick
Dr. Allan Patrick
Fredericton, New Brunswick, Canada, E3B 5B8
Canada, Ontario
The Male/Female Health and Research Centre
Barrie, Ontario, Canada, L4M 7G1
Dr. Stanley Flax
Brampton, Ontario, Canada, L6T 3J1
Brantford Urology Research, Medical Arts Building
Brantford, Ontario, Canada, N3R 4N3
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada, L7N 3V2
Urology Research Centre
Burlington, Ontario, Canada, L7S 1V2
Guelph Urology Associates
Guelph, Ontario, Canada, N1H 5J1
Credit Valley Medical Arts Centre
Mississauga, Ontario, Canada, L5M 4N4
Mor Urology Inc., Bayview Business Centre
Newmarket, Ontario, Canada, L3X 1W1
The Male and Female Health Centre
Oakville, Ontario, Canada, L6H 3P1
Orillia Urology Associates
Orillia, Ontario, Canada, L3V 7V1
Urotec
Oshawa, Ontario, Canada, L1H 1B9
Dr. Todd Webster
Owen Sound, Ontario, Canada, N4K 2J1
Kawartha Urology Associates
Peterborough, Ontario, Canada, K9H 1T6
Dr. Allan Abramovitch
Scarborough, Ontario, Canada, M1S 4V5
Northern Urology Centre
Sudbury, Ontario, Canada, P3E 4T3
The Male Health Centre
Toronto, Ontario, Canada, M6A 3B5
Dr. Roger J. Buckley
Willowdale, Ontario, Canada, M2K 2W1
Canada, Quebec
Urology South Shore Research
Greenfield Park, Quebec, Canada, J4V 2H3
Sponsors and Collaborators
CMX Research
Sanofi
Investigators
Principal Investigator: Richard W Casey, M.D. CMX Research
  More Information

No publications provided

Responsible Party: CMX Research
ClinicalTrials.gov Identifier: NCT00426777     History of Changes
Other Study ID Numbers: SA-CMX-01
Study First Received: January 24, 2007
Last Updated: February 2, 2012
Health Authority: Canada: Health Canada

Keywords provided by CMX Research:
prostate cancer
prostatic adenoma
prostatic neoplasm

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Risedronic acid
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2014