Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00035997

Purpose

The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients.

This prospective, open-label, single arm, multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph. Patients must already be receiving hormone therapy and meet the following additional criteria:

18 years of age or older
Histologically confirmed diagnoses of prostate cancer
Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph
Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments

Throughout the course of this 12-month trial, patients will be identified based on the duration of established hormonal treatment at the time of enrollment. Each patients duration of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a 4 week follow up.

Condition	Intervention	Phase
Prostate Cancer	Drug: Zometa	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Mineral Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Minerals Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months

Secondary Outcome Measures:

Changes in biochemical markers of bone turnover over 12 months
Changes in bone mineral density of the total hip at 12 months
Time to first skeletal-related event
Overall safety measured by adverse events (AEs)

Enrollment:	261
Study Start Date:	April 2002
Study Completion Date:	January 2004
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Signed informed consent
Age > 18 years
Histologically confirmed diagnosis of carcinoma of the prostate
Objective evidence of metastatic disease to the bone as evidenced by bone scan or radiograph at any point since their diagnosis of prostate cancer
Currently receiving, or will begin receiving, hormonal therapy with an LHRH agonist or other hormonal treatments for either < 6 months or > 6 months
ECOG performance status of 0, 1, or 2

Exclusion criteria:

Patients who are hormone sensitive without metastatic disease to the bone
Patients who are hormone refractory typically defined as two or three consecutive increases in PSA measured at least one month apart while on hormone therapy
Patients who are not treated with LHRH agonist or other hormonal treatments
Patients who are currently receiving diethylstilbestrol (DES) or PC-SPES
Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
Patients with abnormal renal function as evidenced by either a serum creatinine greater than 2 mg/dL or by a calculated creatinine clearance of 60 ml/minute or less
Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035997

Hide Study Locations

Locations

United States, Alabama
Norwood Clinic
Birmingham, Alabama, United States, 35234
United States, Alaska
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States, 99508
United States, California
Urology Associates of Central CA
Fresno, California, United States, 93720
Atlantic Urological Medical Group
Long Beach, California, United States, 90806
Advanced Urology Medical Offices
Los Angeles, California, United States, 90045
Center for Urological Research
La Mesa, California, United States, 91942
Advanced Urology Medical Office
Los Angeles, California, United States, 90045
Advanced Urology Medical Center
Anaheim, California, United States, 92801
United States, Colorado
Urology Associates, P.C.
Denver, Colorado, United States, 80210
Boulder Medical Center
Boulder, Colorado, United States
United States, Florida
Pinellas Urology, Inc.
St. Petersburg, Florida, United States, 33710
Advanced Research Institute
New Port Richey, Florida, United States, 34652
Winter Park Urology Associates
Orlando, Florida, United States, 32803
Marvin Stein, MD
Margate, Florida, United States, 33063
Florida Foundation for Healthcare Research
Ocala, Florida, United States, 34474
Southeastern Urological Center
Tallahassee, Florida, United States, 32308
Atlantic Urological Associates
Daytona Beach, Florida, United States, 32114
Southwest Florida Urologic Association
Fort Myers, Florida, United States
DMI Health Care Group, Inc.
Largo, Florida, United States, 33773
Miami Cancer Institute
Miami, Florida, United States, 33143
Florida Foundation for Healthcare Research
Ocala, Florida, United States, 34474
Urology Associates of Northeast Florida, PA
Orange Park, Florida, United States, 32073
Diagnostic Clinic
Largo, Florida, United States, 33770
United States, Georgia
Georgia Urology Research Institute
Atlanta, Georgia, United States, 30342
United States, Indiana
Ball Memorial Hospital
Muncie, Indiana, United States, 47303
United States, Iowa
Urological Associates PC
Davenport, Iowa, United States, 52807
United States, Maryland
Drs. Werner, Murdock and Francis PA Urology Associates
Greenbelt, Maryland, United States, 20770
United States, Massachusetts
Urology Associates of Middlesex County, Inc.
Marlborough, Massachusetts, United States, 01752
United States, Michigan
Lakeside Urology, P.C.
Saint Joseph, Michigan, United States, 49085
Millennium Medical Center
Southfield, Michigan, United States, 48075
United States, Missouri
Kansas City Urology Care
Kansas City, Missouri, United States, 64131
The Prostate Center of Greater St. Louis
St. Louis, Missouri, United States, 63136
United States, Nevada
American Academy of Urology
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Urological Surgical Associates
Edison, New Jersey, United States
Associates in Urology, LLC
West Orange, New Jersey, United States, 07052
Urology Associates
Stratford, New Jersey, United States
UroResearch, LLC
Morristown, New Jersey, United States, 07960
Shaukat M. Qureshi, MD
Pennsville, New Jersey, United States, 08070
United States, New York
Kingston Urological Assoc.
Kingston, New York, United States, 12401
AccuMed Research Associates
Garden City, New York, United States, 11530
Urological Surgeons of Long Island PC
Garden City, New York, United States, 11530
United States, North Carolina
Matrix Research, LLC
Greenville, North Carolina, United States, 29607
Cary Urology, P.A.
Cary, North Carolina, United States, 27511
United States, Ohio
The Urology Group
Cincinnati, Ohio, United States, 45212
Southwest Urology
Parma, Ohio, United States, 44129
United States, Pennsylvania
James W. Thompson, MD Ltd.
Bryn Mawr, Pennsylvania, United States, 09010
Urologic Surgery, PC
Bala Cynwyd, Pennsylvania, United States, 19004
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Urology Institute of Pittsburgh
Monroeville, Pennsylvania, United States, 15146
Center for Urologic Care of Berks County
West Reading, Pennsylvania, United States, 19611
Roger N. Andrews, MD Inc.
Arcadia, Pennsylvania, United States, 91007
United States, South Carolina
Grand Strand Urology
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Murfreesboro Medical Clinic
Murfreesboro, Tennessee, United States, 37130
Urology Center of the South P.C.
Germantown, Tennessee, United States, 38138
Urology Associates, PA
Nashville, Tennessee, United States, 37209
United States, Texas
Research Across America
Carrollton, Texas, United States, 75010
United States, West Virginia
CAMC Clinical Trials
Charleston, West Virginia, United States, 25304

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Scott L. Pescatore, PharmD.

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CZOL446EUS24, US24
Study First Received:	May 7, 2002
Last Updated:	November 20, 2009
ClinicalTrials.gov Identifier:	NCT00035997 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hormone-sensitive Prostate Cancer
Prostate Cancer
Bone Metastasis

Additional relevant MeSH terms:

Zoledronic acid
Genital Neoplasms, Male
Prostatic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Urogenital Neoplasms
Genital Diseases, Male

Hormones
Pharmacologic Actions
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Neoplasm Metastasis
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009