NCT00181584

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Bone Loss
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Zoledronic acid	Given intravenously once.
OTHER	Placebo	Given intravenously once.

Timeline

• Start date: 2003-09-01
• Primary completion: 2006-02-01
• First posted: 2005-09-16
• Last updated: 2013-07-11

Locations

2 sites across 1 country: United States