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

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. Identifier: NCT00434317
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasm Metastasis Drug: Zoledronic acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
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
Study Start Date : August 2005
Actual Primary Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: ZOL446 Drug: Zoledronic acid

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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 identifier (NCT number): NCT00434317

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Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Pecs, Hungary
Novartis Investigative Site
Szeged, Hungary
Novartis Investigative Site
Szekesfehervar, Hungary
Sponsors and Collaborators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Identifier: NCT00434317    
Other Study ID Numbers: CZOL446EHU03
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Keywords provided by Novartis:
breast cancer
prostate cancer
bone metastasis
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs