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The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

Primary Purpose

Prostate Cancer

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

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring Prostate Cancer, Bone Loss, Osteoporosis, Bone Mineral Density, Androgen Deprivation Therapy

Eligibility Criteria

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

Histologically confirmed diagnosis of carcinoma of the prostate No distant metastases (stage TNMO) (ie. prostate cancer without metastases) Patients within one year at the day of randomization from initiation of androgen deprivation therapy with a LHRH agonist (with or without an antiandrogen) and with the intended duration of androgen deprivation therapy of at least 12 months. Patients may also enter if they have received an orchiectomy (or"ke-ek'te-me) within two weeks of visit 1 Patients who received any prior bisphosphonate therapy in the past 12 months will be excluded Patients who are currently receiving diethylstilbesterol (DES) or PC-SPES (treatment for osteoporosis) will be excluded Patients who have received prior treatment with systemic corticosteroids within the past 12 months will be excluded (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable) Other eligibility criteria may apply

Sites / Locations

  • Millennium Therapeutics & Research
  • Medical Affiliated Research Center
  • Alaska Clinical Research Center
  • Advanced Clinical Therapeutics
  • Donald Gleason, MD
  • Arkansas Urology
  • Advanced Urology Med. Center
  • Atlantic Urological Medical Group
  • San Diego Uro. Research
  • Western Clinical Research
  • Connecticut Surgical Group
  • Grove Hill Urology
  • Atlantic Urological Associates
  • University of Miami School of Medicine, Dept. of Urology
  • Advanced Research Institute, Inc.
  • Urosearch
  • Southeastern Urological Center, PA
  • Medisphere Medical Research Center, LLC
  • The Iowa Clinic, PC, Iowa Urology Research
  • Summitt Clinical Research
  • Millennium Medical Center
  • Quality Clinical Research LLC
  • Associated Urologic Specialist, PA
  • Morristown Memorial Hospital
  • Associates In Urology, LLC
  • AccuMed Research Associates
  • Urological Surgeons of L.I.
  • Staten Island Urological Research, PC
  • The Urology Group
  • Urological Associates, Inc.
  • Mount Vernon Urological Associates
  • Oregon Urology Specialists
  • The Urology Clinic
  • Urologic Associates of Allentown
  • Albert Einstein Medical Center
  • Triangle Urological Group
  • Urologic Surgeons of New England, P.C.
  • University Urological Research Institute
  • Carolina Urologic Research Center
  • Integrity Clinical Research, LLC
  • Urology San Antonio Research
  • Salt Lake Research
  • Seattle Urological Associates
  • Rockwood Clinic

Outcomes

Primary Outcome Measures

Percent change in bone mineral density of the lumbar spine (L2-L4) at one year.

Secondary Outcome Measures

Percent changes in bone mineral density of the total hip
biochemical markers of bone turnover at one year

Full Information

First Posted
July 1, 2003
Last Updated
September 11, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00063609
Brief Title
The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
Official Title
The Effect of Zoledronic Acid Compared to Placebo on Bone Mineral Density in Patients Undergoing Androgen Deprivation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the effect of an investigational drug used intravenously and placebo administered every three months for one year, on bone loss associated with initial androgen deprivation) in men with prostate cancer without metastasis. In order to participate in this trial male patients must be 18 years of age or older and have been diagnosed with prostate cancer without metastasis and within one year of starting their androgen deprivation therapy at the day of randomization onto this trial. In addition, patients who have undergone a recent orchiectomy (or"ke-ek'te-me) (removal of one or two testes) are eligible to participate. Patients who received any prior bisphosphonate therapy or prior treatment with systemic corticosteroids within in the past 12 months are not eligible to participate. Also patients who are receiving treatment for osteoporosis are not eligible to participate. Inclusion into this clinical trial with this investigational drug is based on the protocol entry criteria and evaluation from a participating trial investigator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Bone Loss, Osteoporosis, Bone Mineral Density, Androgen Deprivation Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Primary Outcome Measure Information:
Title
Percent change in bone mineral density of the lumbar spine (L2-L4) at one year.
Secondary Outcome Measure Information:
Title
Percent changes in bone mineral density of the total hip
Title
biochemical markers of bone turnover at one year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Histologically confirmed diagnosis of carcinoma of the prostate No distant metastases (stage TNMO) (ie. prostate cancer without metastases) Patients within one year at the day of randomization from initiation of androgen deprivation therapy with a LHRH agonist (with or without an antiandrogen) and with the intended duration of androgen deprivation therapy of at least 12 months. Patients may also enter if they have received an orchiectomy (or"ke-ek'te-me) within two weeks of visit 1 Patients who received any prior bisphosphonate therapy in the past 12 months will be excluded Patients who are currently receiving diethylstilbesterol (DES) or PC-SPES (treatment for osteoporosis) will be excluded Patients who have received prior treatment with systemic corticosteroids within the past 12 months will be excluded (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable) Other eligibility criteria may apply
Facility Information:
Facility Name
Millennium Therapeutics & Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Medical Affiliated Research Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Alaska Clinical Research Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Advanced Clinical Therapeutics
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Donald Gleason, MD
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Arkansas Urology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Advanced Urology Med. Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Atlantic Urological Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
San Diego Uro. Research
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Western Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Connecticut Surgical Group
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Grove Hill Urology
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Atlantic Urological Associates
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
University of Miami School of Medicine, Dept. of Urology
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Urosearch
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Southeastern Urological Center, PA
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Medisphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
The Iowa Clinic, PC, Iowa Urology Research
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Summitt Clinical Research
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Millennium Medical Center
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Quality Clinical Research LLC
City
Springfield
State/Province
Nebraska
ZIP/Postal Code
68059
Country
United States
Facility Name
Associated Urologic Specialist, PA
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
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 L.I.
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Staten Island Urological Research, PC
City
Staten Island
State/Province
New York
ZIP/Postal Code
10304
Country
United States
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Urological Associates, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Mount Vernon Urological Associates
City
Mount Vernon
State/Province
Ohio
ZIP/Postal Code
43050
Country
United States
Facility Name
Oregon Urology Specialists
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
The Urology Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Urologic Associates of Allentown
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Triangle Urological Group
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Urologic Surgeons of New England, P.C.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
University Urological Research Institute
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Integrity Clinical Research, LLC
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Salt Lake Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Seattle Urological Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98704
Country
United States
Facility Name
Rockwood Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

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