Who is sponsoring NCT00320710?

NCT00320710 is sponsored by Novartis Pharmaceuticals.

What condition does NCT00320710 study?

NCT00320710 studies Breast Cancer.

What drugs are being tested in NCT00320710?

Interventions: Zoledronic acid, Placebo.

What is the status of NCT00320710?

NCT00320710 is currently COMPLETED.

Last reviewed 2014-08-18 · How we verify

A Prospective, Randomized, Double-blind, Stratified, Multi-center, 2-arm Trial of the Continued Efficacy and Safety of Zoledronic Acid (Every 4 Weeks vs. Every 12 Weeks) in in the 2nd Year of Treatment in Patients With Documented Bone Metastases From Breast Cancer

NCT00320710 Phase 3 COMPLETED Results posted

Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1 year with a standard zoledronic acid regimen. Looking at the continued effectiveness and safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This study is prospective, double-blind, stratified, multi-center, and two-arm.

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	416
Start date	2006-02
Completion	2013-07

Conditions

Breast Cancer

Interventions

Zoledronic acid
Placebo

Primary outcomes

Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE) — 52 weeks
An SRE was defined as a pathologic fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone or surgery to bone.

Countries

United States