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Tracking Information | |||||
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First Received Date † | September 12, 2005 | ||||
Last Updated Date | June 24, 2008 | ||||
Start Date † | June 2004 | ||||
Current Primary Outcome Measures † |
Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 months. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00171639 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Percent change in bone mineral density of the total hip (including femoral neck, trochanteric region, and Ward's triangle) following one year of therapy. | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | The Use of Zoledronic Acid in Men on Androgen Deprivation Therapy for Prostate Cancer With Preexisting Osteoporosis | ||||
Official Title † | The Use of Zoledronic Acid in Men on Androgen Deprivation Therapy for Prostate Cancer With Preexisting Osteoporosis | ||||
Brief Summary | This study is being conducted to evaluate the effect of an investigational drug on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT). In order to participate, male patients 18 years and older must be veterans from participating Veterans Administration Medical Centers that are receiving ADT for prostate cancer and have established osteoporosis. |
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Detailed Description | |||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
Condition † | Prostate Cancer | ||||
Intervention † | Drug: Zoledronic acid | ||||
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. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria
Other protocol-defined exclusion criteria may apply. |
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Gender | Male | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | |||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00171639 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Novartis | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Novartis | ||||
Verification Date | June 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |