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

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ClinicalTrials.gov Identifier: NCT00434447
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : February 27, 2017
Sponsor:
Information provided by:
Novartis

Brief 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

Condition or disease Intervention/treatment Phase
Bone Neoplasms Drug: Zoledronic acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : December 2006
Actual Primary Completion Date : September 2009


Arm Intervention/treatment
Experimental: Zoledronic Acid
ZOL446
Drug: Zoledronic acid
Other Name: ZOL446




Primary Outcome Measures :
  1. 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). [ Time Frame: 52 weeks ]


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
Criteria

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


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): NCT00434447


Locations
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Australia, Australian Capital Territory
Novartis Investigative Site
Canberra, Australian Capital Territory, Australia
Australia, New South Wales
Novartis Investigative Site
Concord, New South Wales, Australia
Novartis Investigative Site
Liverpool, New South Wales, Australia
Novartis Investigative Site
Wagga Wagga, New South Wales, Australia
Australia, Queensland
Novartis Investigative Site
Redcliffe, Queensland, Australia
Novartis Investigative Site
Townsville, Queensland, Australia
Novartis Investigative Site
Woolloongabba, Queensland, Australia
Australia, Victoria
Novartis Investigative Site
Ballarat, Victoria, Australia
Novartis Investigative Site
Box Hill, Victoria, Australia
Novartis Investigative Site
Frankston, Victoria, Australia
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals

Additional Information:
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Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00434447     History of Changes
Other Study ID Numbers: CZOL446EAU22
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: October 2010
Keywords provided by Novartis:
Prostate Cancer
Breast Cancer
Multiple Myeloma
Zoledronic acid
Bone metastases
Skeletal Related Events (SREs)
Renal Impairment
Osteonecrosis of the Jaw (ONJ)
Bone involvement
Multiple Myeloma (MM)
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasm Metastasis
Bone Neoplasms
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs