|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 24, 2007 | ||||
| Last Updated Date | February 26, 2008 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
bone mineral density of the lumbar spine [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
bone mineral density of the lumbar spine | ||||
| Change History | Complete list of historical versions of study NCT00426777 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
overall safety [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
overall safety | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
||||
| 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. |
||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 160 | ||||
| Estimated Completion Date | February 2009 | ||||
| Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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.
|
||||
| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00426777 | ||||
| Responsible Party | Carlo Mendoza, VP Contract Research Services, CMX Research | ||||
| Study ID Numbers ICMJE | SA-CMX-01 | ||||
| Study Sponsor ICMJE | CMX Research | ||||
| Collaborators ICMJE | Sanofi-Aventis | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | CMX Research | ||||
| Verification Date | February 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||