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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma Breast Cancer	Drug: Zoledronic acid	Phase I

Genetics Home Reference related topics:

aceruloplasminemia breast cancer hemophilia

MedlinePlus related topics:

Breast Cancer Cancer Multiple Myeloma

ChemIDplus related topics:

Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study

Official Title:	A Stratified, Randomized, Open-Label, Multi-Center Comparative 2-Arm Trial of PK, PD, and Safety of Zoledronic Acid Infusions Administered Monthly vs. Every 3-Month, in Multiple Myeloma Patients With Malignant Bone Lesions, and Breast Cancer Patients With Bone Metastasis, Who Have Received 9-12* Doses of Zoledronic Acid Over the Prior Year. (*Amendment 1 Changed the Required Doses to 9-20 But Due to FDA Guidelines, the Title Has Not Been Changed)

Further study details as provided by Novartis:

Primary Outcome Measures:

Pharmacokinetic outcomes will be measured by the following:
Sequential plasma concentrations of zoledronic acid [ Time Frame: collected at 13 study visits between visit 2 to visit 17 ]
Sequential urine concentrations of zoledronic acid [ Time Frame: collected at 9 study visits between visit 2 to visit 13 ]

Secondary Outcome Measures:

Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers. [ Time Frame: at all visits ]
Efficacy outcomes will be measured by number and time to skeletal related events (determined by bone surveys and bone scans) as well as the measurement of pain and analgesic scores. [ Time Frame: throughout the study ]

Estimated Enrollment:	72
Study Start Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424983

Contacts


Contact: Novartis	862 778 8300

Locations


United States, California
	Oncotherapeutics	Recruiting
	West Hollywood, California, United States, 90069
	Contact: Regina Swift 310-623-1227
	Sub-Investigator: James Berenson, M.D.

United States, Connecticut
	Norwalk Hospital	Recruiting
	Norwalk, Connecticut, United States, 06856
	Contact: Jennifer Long 203-852-2996 Jennifer.Long@norwalkhealth.org
	Principal Investigator: Richard Frank, M.D.

United States, New York
	Montefiore Medical Center	Active, not recruiting
	Bronx, New York, United States, 10467

United States, Vermont
	Fletcher Allen Health Care	Recruiting
	Burlington, Vermont, United States, 05401
	Contact: Jim Fingar 802-656-9924 james.fingar@med.uvm.edu
	Principal Investigator: Barbara Grant, M.D.

United States, Virginia
	Virginia Cancer Center	Recruiting
	Richmond, Virginia, United States, 23230
	Contact: Jean Bear 804-288-7159 jbear@vacancer.com
	Principal Investigator: David Treat, M.D.

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Study ID Numbers:	CZOL446E2105
First Received:	January 19, 2007
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00424983
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Multiple myeloma

breast cancer

zoledronic acid

pharmacokinetics

Study placed in the following topic categories:

Zoledronic acid

Immunoproliferative Disorders

Skin Diseases

Blood Protein Disorders

Hematologic Diseases

Blood Coagulation Disorders

Vascular Diseases

Breast Neoplasms

Paraproteinemias

Hemostatic Disorders

Multiple Myeloma

Diphosphonates

Hemorrhagic Disorders

Multiple myeloma

Neoplasm Metastasis

Lymphoproliferative Disorders

Breast Diseases

Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

Immune System Diseases

Physiological Effects of Drugs

Bone Density Conservation Agents

Cardiovascular Diseases

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00424983