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
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
2 other identifiers
interventional
261
1 country
56
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 prostate-cancer
Started Apr 2002
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 7, 2002
CompletedFirst Posted
Study publicly available on registry
May 8, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedNovember 23, 2009
November 1, 2009
1.8 years
May 7, 2002
November 20, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months
Secondary Outcomes (4)
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)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Norwood Clinic
Birmingham, Alabama, 35234, United States
Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99508, United States
Advanced Urology Medical Center
Anaheim, California, 92801, United States
Urology Associates of Central CA
Fresno, California, 93720, United States
Center for Urological Research
La Mesa, California, 91942, United States
Atlantic Urological Medical Group
Long Beach, California, 90806, United States
Advanced Urology Medical Offices
Los Angeles, California, 90045, United States
Advanced Urology Medical Office
Los Angeles, California, 90045, United States
Boulder Medical Center
Boulder, Colorado, United States
Urology Associates, P.C.
Denver, Colorado, 80210, United States
Atlantic Urological Associates
Daytona Beach, Florida, 32114, United States
Southwest Florida Urologic Association
Fort Myers, Florida, United States
Diagnostic Clinic
Largo, Florida, 33770, United States
DMI Health Care Group, Inc.
Largo, Florida, 33773, United States
Marvin Stein, MD
Margate, Florida, 33063, United States
Miami Cancer Institute
Miami, Florida, 33143, United States
Advanced Research Institute
New Port Richey, Florida, 34652, United States
Florida Foundation for Healthcare Research
Ocala, Florida, 34474, United States
Urology Associates of Northeast Florida, PA
Orange Park, Florida, 32073, United States
Winter Park Urology Associates
Orlando, Florida, 32803, United States
Pinellas Urology, Inc.
St. Petersburg, Florida, 33710, United States
Southeastern Urological Center
Tallahassee, Florida, 32308, United States
Georgia Urology Research Institute
Atlanta, Georgia, 30342, United States
Ball Memorial Hospital
Muncie, Indiana, 47303, United States
Urological Associates PC
Davenport, Iowa, 52807, United States
Drs. Werner, Murdock and Francis PA Urology Associates
Greenbelt, Maryland, 20770, United States
Urology Associates of Middlesex County, Inc.
Marlborough, Massachusetts, 01752, United States
Lakeside Urology, P.C.
Saint Joseph, Michigan, 49085, United States
Millennium Medical Center
Southfield, Michigan, 48075, United States
Kansas City Urology Care
Kansas City, Missouri, 64131, United States
The Prostate Center of Greater St. Louis
St Louis, Missouri, 63136, United States
American Academy of Urology
Las Vegas, Nevada, 89119, United States
Urological Surgical Associates
Edison, New Jersey, United States
UroResearch, LLC
Morristown, New Jersey, 07960, United States
Shaukat M. Qureshi, MD
Pennsville, New Jersey, 08070, United States
Urology Associates
Stratford, New Jersey, United States
Associates in Urology, LLC
West Orange, New Jersey, 07052, United States
AccuMed Research Associates
Garden City, New York, 11530, United States
Urological Surgeons of Long Island PC
Garden City, New York, 11530, United States
Kingston Urological Assoc.
Kingston, New York, 12401, United States
Cary Urology, P.A.
Cary, North Carolina, 27511, United States
Matrix Research, LLC
Greenville, North Carolina, 29607, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Southwest Urology
Parma, Ohio, 44129, United States
Roger N. Andrews, MD Inc.
Arcadia, Pennsylvania, 91007, United States
Urologic Surgery, PC
Bala-Cynwyd, Pennsylvania, 19004, United States
James W. Thompson, MD Ltd.
Bryn Mawr, Pennsylvania, 09010, United States
Urology Institute of Pittsburgh
Monroeville, Pennsylvania, 15146, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Center for Urologic Care of Berks County
West Reading, Pennsylvania, 19611, United States
Grand Strand Urology
Myrtle Beach, South Carolina, 29572, United States
Urology Center of the South P.C.
Germantown, Tennessee, 38138, United States
Murfreesboro Medical Clinic
Murfreesboro, Tennessee, 37130, United States
Urology Associates, PA
Nashville, Tennessee, 37209, United States
Research Across America
Carrollton, Texas, 75010, United States
CAMC Clinical Trials
Charleston, West Virginia, 25304, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Scott L. Pescatore, PharmD.
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 7, 2002
First Posted
May 8, 2002
Study Start
April 1, 2002
Primary Completion
January 1, 2004
Study Completion
January 1, 2004
Last Updated
November 23, 2009
Record last verified: 2009-11