Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year

NCT ID: NCT00424983

Last Updated: 2020-12-21

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

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-11-30

Brief Summary

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The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK) profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.

Detailed Description

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Conditions

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Multiple Myeloma Breast Cancer

Keywords

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Multiple myeloma breast cancer zoledronic acid pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zometa q 4 weeks

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Zometa q 12 weeks

Group Type ACTIVE_COMPARATOR

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

* Male or female between 18-75 years of age
* Multiple myeloma or breast cancer with bone involvement
* Treatment with zoledronic acid for bone lesions between 10-15 months prior to entry into study with a total of 9-20 infusions received.

Exclusion Criteria

* Current active dental problems or recent (within 8 weeks) or planned dental or jaw surgery
* Active or uncontrolled infection, liver, or renal disease
* History of treatment with intravenous bisphosphonates
* Diagnosis of metabolic bone disorders other than osteoporosis (e.g. Paget's disease)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis

Role: STUDY_CHAIR

Novartis

Locations

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Oncotherapeutics

West Hollywood, California, United States

Site Status

Rocky Mountain Cancer Centers RMCC

Greenwood Village, Colorado, United States

Site Status

Norwalk Hospital

Norwalk, Connecticut, United States

Site Status

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Huntsman Cancer Institute Univ. of Utah

Salt Lake City, Utah, United States

Site Status

University of Vermont Fletcher Allen Health Care

Burlington, Vermont, United States

Site Status

Virginia Cancer Institute Virginia Cancer Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Related Links

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https://www.novartisclinicaltrials.com/TrialConnectWeb/home.nov

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7464

Results for CZOL446E2105 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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2007-004719-73

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CZOL446E2105

Identifier Type: -

Identifier Source: org_study_id