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OpenTrials
Completed

NCT Number: NCT00029224

Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions

Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be evaluated, as well as time in chair, quality of life and safety of Zometa.

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Key information

Conditions

Breast Cancer Blood Protein Disorders Breast Diseases Breast Neoplasms Cardiovascular Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Male Urogenital Diseases Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Neurologic Manifestations Pain Paraproteinemias Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stockton Hematology Oncology Medical Group, Stockton, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent
  • Greater than 18 years of age
  • Proof of breast cancer, multiple myeloma or prostate cancer
  • Diagnosis of at least one cancer-related bone lesion
  • If patient is of child-bearing potential, negative pregnancy test and on a medically recognized form of contraception
  • ECOG performance status of 0,1 or 2
  • Ability to read, understand and write English or Spanish language
  • Normal renal function
  • Corrected serum calcium equal to or greater than 8mg/dl Exclusion Criteria
  • clinically symptomatic brain metastases
  • hypersensitivity to Zometa or other bisphosphonates
  • pregnant or lactating

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

  1. Pain score assessed by change from baseline

Secondary outcomes

  1. Quality of life

  2. Time in infusion chair

  3. Safety assessed by adverse events (AEs)

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Prospective, Multicenter, Open-label Clinical Evaluation of the Effect of IV Zoledronic Acid 4mg on PAIN, QUALITY OF LIFE and TIME IN INFUSION CHAIR in Breast Cancer, Multiple Myeloma, and Prostate Cancer Patients With Cancer-related Bone Lesions

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Jan 10, 2002
Registry last updated
Feb 1, 2012

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.

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