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Trial record 10 of 101 for:    Risedronate

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00426777
Recruitment Status : Completed
First Posted : January 25, 2007
Last Update Posted : February 3, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: risedronate Drug: Control Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : January 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. bone mineral density of the lumbar spine [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. overall safety [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00426777

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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
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
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Principal Investigator: Richard W Casey, M.D. CMX Research

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Responsible Party: CMX Research Identifier: NCT00426777     History of Changes
Other Study ID Numbers: SA-CMX-01
First Posted: January 25, 2007    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
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Risedronic Acid
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents