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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00029224

Enrollment

500

Registered

2002-01-10

Start date

2001-10-31

Completion date

2002-11-30

Last updated

2012-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Multiple Myeloma, Prostate Cancer

Keywords

bone lesions, breast cancer, multiple myeloma, prostate cancer, bone metastases, pain

Brief summary

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.

Interventions

DRUGzoledronic acid

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pain score assessed by change from baseline	—

Secondary

Measure	Time frame
Quality of life	—
Time in infusion chair	—
Safety assessed by adverse events (AEs)	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026