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Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer
This study is ongoing, but not recruiting participants.
Study NCT00426777   Information provided by CMX Research
First Received: January 24, 2007   Last Updated: February 26, 2008   History of Changes

January 24, 2007
February 26, 2008
January 2007
January 2009   (final data collection date for primary outcome measure)
bone mineral density of the lumbar spine [ Time Frame: 12 months ] [ Designated as safety issue: No ]
bone mineral density of the lumbar spine
Complete list of historical versions of study NCT00426777 on ClinicalTrials.gov Archive Site
overall safety [ Time Frame: 12 months ] [ Designated as safety issue: No ]
overall safety
 
Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer
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

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.

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.

Phase III
Interventional
Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Prostate Cancer
  • Drug: risedronate
  • Drug: Control
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
160
February 2009
January 2009   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00426777
Carlo Mendoza, VP Contract Research Services, CMX Research
SA-CMX-01
CMX Research
Sanofi-Aventis
Principal Investigator: Richard W Casey, M.D. CMX Research
CMX Research
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP