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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00434317
First received: February 9, 2007
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life assessment at baseline and last visit [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434317

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00434317     History of Changes
Other Study ID Numbers: CZOL446EHU03
Study First Received: February 9, 2007
Last Updated: August 6, 2012
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Novartis:
Metastasis
Neoplasm
pain
breast cancer
prostate cancer
bone metastasis

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

ClinicalTrials.gov processed this record on September 16, 2014