Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases

A Multicenter, Open-label Study to Determine the Effect of iv. Zoledronic Acid on Pain and Quality of Life in Patients With Bone Metastases With or Without Skeletal Related Events (SRE) Resulting From Breast Cancer and Prostate Cancer

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00434317

Enrollment

Registered

2007-02-13

Start date

2005-08-31

Completion date

Unknown

Last updated

2017-02-23

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

Conditions

Neoplasm Metastasis

Keywords

Metastasis, Neoplasm, pain, breast cancer, prostate cancer, bone metastasis

Brief summary

This study will evaluate the safety, tolerability and efficacy of zoledronic acid administered intravenously every 3-4 weeks in patients with bone metastases from either breast cancer or prostate cancer.

Interventions

DRUGZoledronic acid

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Ambulatory patients \>18 years * Proof of breast cancer or prostate cancer * Diagnosis of at least one cancer-related bone lesion that is detectable on conventional radiographs or bone scan at screening * Negative pregnancy test * ECOG performance status of 0,1 or 2

Exclusion criteria

* Patients with abnormal renal function * Patients with clinically symptomatic brain metastases * Known hypersensitivity on zoledronic acid or other bisphosphonates * Pregnancy or lactation Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Measurement of pain assessed by a Visual Analogue Scale (VAS)	throughout the study

Secondary

Measure	Time frame
Quality of Life assessment at baseline and last visit	throughout the study

Countries

Hungary

Outcome results

None listed

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