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

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

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Key information

Conditions

Bone Neoplasms Blood Protein Disorders Bone Diseases Breast Diseases Breast Neoplasms Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Kidney Diseases Lymphoproliferative Disorders Male Urogenital Diseases Multiple Myeloma Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Prostatic Diseases Prostatic Neoplasms Renal Insufficiency Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Canberra, Australian Capital Territory, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoledronic acid

Drug

Other names: ZOL446

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2009
First posted: Feb 13, 2007
Registry last updated: Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed