Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Dana-Farber Cancer Institute
• Treatments: Androgens; Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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