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

Novartis

Status and phase: Completed; Phase 4

Conditions: Breast Cancer; Multiple Myeloma; Prostate Cancer

Treatments: Drug: zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00029224

CZOL446EUS16

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)