Status:
COMPLETED
Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Bone Loss
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to determine whether zoledronic acid (Zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer.
Detailed Description
* 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 ...
Eligibility Criteria
Inclusion
- Adenocarcinoma of the prostate
- Current androgen deprivation therapy with expected duration of treatment greater than or equal to 12 months
- Corrected serum calcium \> 8.4mg/dl and \< 10.6mg/dl
- Serum creatinine \< 2.0mg/dl
Exclusion
- History of bone metastases by bone scan
- Treatment with bisphosphonate within one year
- History of metabolic disease
- Chronic use of glucocorticoids, anticonvulsants, or suppressive doses of thyroxine within one year
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00181584
Start Date
September 1 2003
Last Update
July 11 2013
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115