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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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zometa
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Hormone-sensitive Prostate Cancer, Prostate Cancer, Bone Metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Norwood Clinic
  • Alaska Clinical Research Center, LLC
  • Advanced Urology Medical Center
  • Urology Associates of Central CA
  • Center for Urological Research
  • Atlantic Urological Medical Group
  • Advanced Urology Medical Offices
  • Advanced Urology Medical Office
  • Boulder Medical Center
  • Urology Associates, P.C.
  • Atlantic Urological Associates
  • Southwest Florida Urologic Association
  • Diagnostic Clinic
  • DMI Health Care Group, Inc.
  • Marvin Stein, MD
  • Miami Cancer Institute
  • Advanced Research Institute
  • Florida Foundation for Healthcare Research
  • Urology Associates of Northeast Florida, PA
  • Winter Park Urology Associates
  • Pinellas Urology, Inc.
  • Southeastern Urological Center
  • Georgia Urology Research Institute
  • Ball Memorial Hospital
  • Urological Associates PC
  • Drs. Werner, Murdock and Francis PA Urology Associates
  • Urology Associates of Middlesex County, Inc.
  • Lakeside Urology, P.C.
  • Millennium Medical Center
  • Kansas City Urology Care
  • The Prostate Center of Greater St. Louis
  • American Academy of Urology
  • Urological Surgical Associates
  • UroResearch, LLC
  • Shaukat M. Qureshi, MD
  • Urology Associates
  • Associates in Urology, LLC
  • AccuMed Research Associates
  • Urological Surgeons of Long Island PC
  • Kingston Urological Assoc.
  • Cary Urology, P.A.
  • Matrix Research, LLC
  • The Urology Group
  • Southwest Urology
  • Roger N. Andrews, MD Inc.
  • Urologic Surgery, PC
  • James W. Thompson, MD Ltd.
  • Urology Institute of Pittsburgh
  • Albert Einstein Medical Center
  • Center for Urologic Care of Berks County
  • Grand Strand Urology
  • Urology Center of the South P.C.
  • Murfreesboro Medical Clinic
  • Urology Associates, PA
  • Research Across America
  • CAMC Clinical Trials

Outcomes

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)

Full Information

First Posted
May 7, 2002
Last Updated
November 20, 2009
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00035997
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Hormone-sensitive Prostate Cancer, Prostate Cancer, Bone Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zometa
Primary Outcome Measure Information:
Title
Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months
Secondary Outcome Measure Information:
Title
Changes in biochemical markers of bone turnover over 12 months
Title
Changes in bone mineral density of the total hip at 12 months
Title
Time to first skeletal-related event
Title
Overall safety measured by adverse events (AEs)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott L. Pescatore, PharmD.
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Norwood Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35234
Country
United States
Facility Name
Alaska Clinical Research Center, LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Advanced Urology Medical Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Urology Associates of Central CA
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Center for Urological Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Atlantic Urological Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Advanced Urology Medical Offices
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Advanced Urology Medical Office
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Boulder Medical Center
City
Boulder
State/Province
Colorado
Country
United States
Facility Name
Urology Associates, P.C.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Atlantic Urological Associates
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Southwest Florida Urologic Association
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Diagnostic Clinic
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
DMI Health Care Group, Inc.
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Marvin Stein, MD
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Advanced Research Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Florida Foundation for Healthcare Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Urology Associates of Northeast Florida, PA
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Winter Park Urology Associates
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Pinellas Urology, Inc.
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Southeastern Urological Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Georgia Urology Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Ball Memorial Hospital
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Urological Associates PC
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
Drs. Werner, Murdock and Francis PA Urology Associates
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Urology Associates of Middlesex County, Inc.
City
Marlborough
State/Province
Massachusetts
ZIP/Postal Code
01752
Country
United States
Facility Name
Lakeside Urology, P.C.
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Millennium Medical Center
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Kansas City Urology Care
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
The Prostate Center of Greater St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
American Academy of Urology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Urological Surgical Associates
City
Edison
State/Province
New Jersey
Country
United States
Facility Name
UroResearch, LLC
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Shaukat M. Qureshi, MD
City
Pennsville
State/Province
New Jersey
ZIP/Postal Code
08070
Country
United States
Facility Name
Urology Associates
City
Stratford
State/Province
New Jersey
Country
United States
Facility Name
Associates in Urology, LLC
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Urological Surgeons of Long Island PC
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Kingston Urological Assoc.
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Cary Urology, P.A.
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
Matrix Research, LLC
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Southwest Urology
City
Parma
State/Province
Ohio
ZIP/Postal Code
44129
Country
United States
Facility Name
Roger N. Andrews, MD Inc.
City
Arcadia
State/Province
Pennsylvania
ZIP/Postal Code
91007
Country
United States
Facility Name
Urologic Surgery, PC
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
James W. Thompson, MD Ltd.
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
09010
Country
United States
Facility Name
Urology Institute of Pittsburgh
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Center for Urologic Care of Berks County
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Grand Strand Urology
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Urology Center of the South P.C.
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Murfreesboro Medical Clinic
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Urology Associates, PA
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Research Across America
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
CAMC Clinical Trials
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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