Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases

Bone Neoplasms Clinical Trial

Official title:

A Phase IV Study of Zoledronic Acid Therapy in Patients With Bone Metastases From Breast Cancer or Hormone Resistant Prostate Cancer, or Bone Involvement From Multiple Myeloma, Assessing Long-term Efficacy and Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434447
• Other study ID #: CZOL446EAU22
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2007
• Last updated: February 23, 2017
• Start date: December 2006

Study information

• Verified date: October 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to monitor the safety and efficacy of long-term treatment with zoledronic acid by assessing the incidence of, renal impairment, osteonecrosis of the jaw(ONJ), overall safety and skeletal related events (SREs) beyond 12 months treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Documented bone metastases from breast cancer, prostate cancer or multiple myeloma

• Prior treatment with zoledronic acid for 1-2 yrs

• Life expectancy of at least 6 months

Exclusion criteria:

• Prior treatment with bisphosphonates other than zoledronic acid

• Abnormal kidney function

• Current or previous dental problems or planned dental surgery

• Pregnant or likely to become pregnant during the study

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Bone Neoplasms
• Multiple Myeloma
• Neoplasm Metastasis

Intervention

Drug:
• Zoledronic acid

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Ballarat	Victoria
Australia	Novartis Investigative Site	Box Hill	Victoria
Australia	Novartis Investigative Site	Canberra	Australian Capital Territory
Australia	Novartis Investigative Site	Concord	New South Wales
Australia	Novartis Investigative Site	Frankston	Victoria
Australia	Novartis Investigative Site	Liverpool	New South Wales
Australia	Novartis Investigative Site	Redcliffe	Queensland
Australia	Novartis Investigative Site	Townsville	Queensland
Australia	Novartis Investigative Site	Wagga Wagga	New South Wales
Australia	Novartis Investigative Site	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by incidence of renal impairment, osteonecrosis of the Jaw (ONJ), adverse events and serious adverse events. Efficacy assessed by incidence of skeletal related events (SREs).		52 weeks

External Links

•   Results for CZOL446EAU22 from the Novartis Clinical Trials website