Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00181584|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bone Loss Prostate Cancer||Drug: Zoledronic acid Other: Placebo||Phase 2|
- Patients will be randomized into 2 groups. At the screening visit, a bone mineral density test will be performed to determine if the patient has osteoporosis or not. Patients with osteoporosis will be treated with Zometa. Patients without osteoporosis will be randomly assigned to receive either Zometa or a placebo.
- Zometa is administered intravenously over a 15 minute prior once in this one year study.
- All patients will asked to take an over-the-counter oral calcium (500mg daily) and a daily multi-vitamin (containing 400-500 I.U of vitamin D) during the study.
- All patients will have clinic visits every 3 months for blood tests and to report any side effects they may be experiencing. At month 12, a bone mineral density test will be repeated.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||February 2006|
|Active Comparator: Group 1||
Drug: Zoledronic acid
Given intravenously once.
Other Name: Zometa
|Placebo Comparator: Group 2||
Given intravenously once.
- To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo. [ Time Frame: 3 years ]
- To compare changes in biochemical markers of bone turnover between men treated with zoledronic acid and men treated with placebo [ Time Frame: 3 years ]
- to assess the safety and tolerability of zoledronic acid. [ Time Frame: 3 years ]
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 ClinicalTrials.gov identifier (NCT number): NCT00181584
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Matthew Smith, MD||Massachusetts General Hospital|