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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

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

Study ID: NCT00035997

Conditions

Prostate Cancer

Interventions

Zometa

Study Description

Brief Summary: 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Norwood Clinic, Birmingham, Alabama, United States

Alaska Clinical Research Center, LLC, Anchorage, Alaska, United States

Advanced Urology Medical Center, Anaheim, California, United States

Urology Associates of Central CA, Fresno, California, United States

Center for Urological Research, La Mesa, California, United States

Atlantic Urological Medical Group, Long Beach, California, United States

Advanced Urology Medical Offices, Los Angeles, California, United States

Advanced Urology Medical Office, Los Angeles, California, United States

Boulder Medical Center, Boulder, Colorado, United States

Urology Associates, P.C., Denver, Colorado, United States

Atlantic Urological Associates, Daytona Beach, Florida, United States

Southwest Florida Urologic Association, Fort Myers, Florida, United States

Diagnostic Clinic, Largo, Florida, United States

DMI Health Care Group, Inc., Largo, Florida, United States

Marvin Stein, MD, Margate, Florida, United States

Miami Cancer Institute, Miami, Florida, United States

Advanced Research Institute, New Port Richey, Florida, United States

Florida Foundation for Healthcare Research, Ocala, Florida, United States

Urology Associates of Northeast Florida, PA, Orange Park, Florida, United States

Winter Park Urology Associates, Orlando, Florida, United States

Pinellas Urology, Inc., St. Petersburg, Florida, United States

Southeastern Urological Center, Tallahassee, Florida, United States

Georgia Urology Research Institute, Atlanta, Georgia, United States

Ball Memorial Hospital, Muncie, Indiana, United States

Urological Associates PC, Davenport, Iowa, United States

Drs. Werner, Murdock and Francis PA Urology Associates, Greenbelt, Maryland, United States

Urology Associates of Middlesex County, Inc., Marlborough, Massachusetts, United States

Lakeside Urology, P.C., Saint Joseph, Michigan, United States

Millennium Medical Center, Southfield, Michigan, United States

Kansas City Urology Care, Kansas City, Missouri, United States

The Prostate Center of Greater St. Louis, St. Louis, Missouri, United States

American Academy of Urology, Las Vegas, Nevada, United States

Urological Surgical Associates, Edison, New Jersey, United States

UroResearch, LLC, Morristown, New Jersey, United States

Shaukat M. Qureshi, MD, Pennsville, New Jersey, United States

Urology Associates, Stratford, New Jersey, United States

Associates in Urology, LLC, West Orange, New Jersey, United States

AccuMed Research Associates, Garden City, New York, United States

Urological Surgeons of Long Island PC, Garden City, New York, United States

Kingston Urological Assoc., Kingston, New York, United States

Cary Urology, P.A., Cary, North Carolina, United States

Matrix Research, LLC, Greenville, North Carolina, United States

The Urology Group, Cincinnati, Ohio, United States

Southwest Urology, Parma, Ohio, United States

Roger N. Andrews, MD Inc., Arcadia, Pennsylvania, United States

Urologic Surgery, PC, Bala Cynwyd, Pennsylvania, United States

James W. Thompson, MD Ltd., Bryn Mawr, Pennsylvania, United States

Urology Institute of Pittsburgh, Monroeville, Pennsylvania, United States

Albert Einstein Medical Center, Philadelphia, Pennsylvania, United States

Center for Urologic Care of Berks County, West Reading, Pennsylvania, United States

Grand Strand Urology, Myrtle Beach, South Carolina, United States

Urology Center of the South P.C., Germantown, Tennessee, United States

Murfreesboro Medical Clinic, Murfreesboro, Tennessee, United States

Urology Associates, PA, Nashville, Tennessee, United States

Research Across America, Carrollton, Texas, United States

CAMC Clinical Trials, Charleston, West Virginia, United States

Contact Details

Name: Scott L. Pescatore, PharmD.

Affiliation: Novartis

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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