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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00434447

Enrollment

Registered

2007-02-13

Start date

2006-12-31

Completion date

Unknown

Last updated

2017-02-27

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

Conditions

Bone Neoplasms

Keywords

Prostate Cancer, Breast Cancer, Multiple Myeloma, Zoledronic acid, Bone metastases, Skeletal Related Events (SREs), Renal Impairment, Osteonecrosis of the Jaw (ONJ), Bone involvement, Multiple Myeloma (MM)

Brief summary

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

Interventions

DRUGZoledronic acid

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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).	52 weeks

Countries

Australia

Outcome results

None listed

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