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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Bone Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Zoledronic Acid

ZOL446

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Interventions

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Zoledronic acid

Intervention Type DRUG

Other Intervention Names

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ZOL446

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No