NCT00697619

To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer

A Prospective, Open-label, Randomized Phase III Study to Evaluate the Efficacy of ZOMETA® (Zoledronic Acid) in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic treatment alone.

Conditions

• Nasopharyngeal Cancer

Interventions

Type	Name	Description
DRUG	Zometa (zoledronic acid)	Zometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily

Timeline

• Start date: 2005-09-01
• Primary completion: 2009-01-01
• Completion: 2009-09-01
• First posted: 2008-06-16
• Last updated: 2012-03-07
• Results posted: 2012-03-02

Locations

1 site across 1 country: China