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Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 13, 2007
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
This study will evaluate the safety, tolerability and efficacy of zoledronic acid administered intravenously every 3-4 weeks in patients with bone metastases from either breast cancer or prostate cancer.

Condition Intervention Phase
Neoplasm Metastasis Drug: Zoledronic acid Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Study to Determine the Effect of iv. Zoledronic Acid on Pain and Quality of Life in Patients With Bone Metastases With or Without Skeletal Related Events (SRE) Resulting From Breast Cancer and Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measurement of pain assessed by a Visual Analogue Scale (VAS) [ Time Frame: throughout the study ]

Secondary Outcome Measures:
  • Quality of Life assessment at baseline and last visit [ Time Frame: throughout the study ]

Enrollment: 80
Study Start Date: August 2005
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZOL446 Drug: Zoledronic acid


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Ambulatory patients >18 years
  • Proof of breast cancer or prostate cancer
  • Diagnosis of at least one cancer-related bone lesion that is detectable on conventional radiographs or bone scan at screening
  • Negative pregnancy test
  • ECOG performance status of 0,1 or 2

Exclusion criteria:

  • Patients with abnormal renal function
  • Patients with clinically symptomatic brain metastases
  • Known hypersensitivity on zoledronic acid or other bisphosphonates
  • Pregnancy or lactation

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434317

Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Pecs, Hungary
Novartis Investigative Site
Szeged, Hungary
Novartis Investigative Site
Szekesfehervar, Hungary
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00434317     History of Changes
Other Study ID Numbers: CZOL446EHU03
First Submitted: February 9, 2007
First Posted: February 13, 2007
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
breast cancer
prostate cancer
bone metastasis

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs