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Completed Phase 3 Interventional

Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy

ClinicalTrials.gov ID: NCT00129142

Public ClinicalTrials.gov record NCT00129142. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 12:05 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural hormone called testosterone. This type of therapy is very effective for the treatment of prostate cancer. However, one of the side effects is bone loss or thinning of the bones that can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones). The purpose of the study is to determine whether or not the addition of toremifene citrate (the study drug) to therapy can prevent or decrease the number of bone fractures and to evaluate its impact on side effects associated with testosterone reduction therapy.

Study identification

NCT ID
NCT00129142
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
GTx
Industry
Enrollment
1,200 participants

Conditions and interventions

Eligibility (public fields only)

Age range
50 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2003 (Type not available)
Primary completion
Nov 2007 (Actual)
Completion
Nov 2007 (Actual)
Last update posted
Nov 15, 2013

2003 – 2007

United States locations

U.S. sites
136
U.S. states
37
U.S. cities
120
Facility City State ZIP Site status
Urology Centers of Alabama Homewood Alabama 35209 —
Coastal Clinical Research Mobile Alabama 36608 —
Arkansas Urology Little Rock Arkansas 72211 —
Advanced Urology Medical Center Clinical Trials Anaheim California 92801 —
Urological Sciences Research Foudation Culver City California 90232 —
Urological Associates of Central CA Fresno California 93720 —
Center of Urologic Research La Mesa California 91942 —
South Orange County Medical Research Center Laguna Woods California 92653 —
Palo Alto VA Palo Alto California 94305 —
San Bernadino Urological Associates San Bernadino California 92404 —
Urological Physicians of San Diego San Diego California 92103 —
Veterans Medical Research Foundation San Diego California 92161 —
Pacific Clinical Research Santa Monica California 90404 —
West Coast Clinical Research Tarzana California 91356 —
Western Clinical Research, Inc. Torrance California 90505 —
Urology Associates Denver Colorado 80210 —
Western Urological Research Wheat Ridge Colorado 80033 —
Urologic Center New Haven Connecticut 06511 —
Urological Associates of Bridgeport Trumball Connecticut 06611 —
Connecticut Clinical Research Waterbury Connecticut 06708 —
Walter Reed Army Medical Center Washington D.C. District of Columbia 20307 —
South Florida Medical Research Aventura Florida 33180 —
Urology Consultants Inc. Clearwater Florida 33761 —
Atlantic Urological Associates Daytona Beach Florida 32114 —
Urosearch Inverness Florida 34452 —
Lakeland Regional Medical Center Lakeland Florida 33805 —
Advance Research Institute New Port Richey Florida 34652 —
Central Florida Urology Group/ UroSearch Ocala Florida 34474 —
Florida Foundation for Healthcare Research Ocala Florida 34474 —
Winter Park Urology Associates Orlando Florida 32803 —
Panama City Urology Panama City Beach Florida 32405 —
Pinellas Urology St. Petersburg Florida 33710 —
Southeastern Research Group Tallahassee Florida 32308 —
Tampa Bay Urology Tampa Florida 33607 —
UroSearch Tavares Florida 32778 —
Cleveland Clinic-Florida Weston Florida 33331 —
Midtown Urology Atlanta Georgia 30308 —
Georgia Urology Atlanta Georgia 30342 —
St. Joseph Research Institute Atlanta Georgia 30342 —
Augusta VAMC Augusta Georgia 30912 —
Southeastern Medical Research Institute Columbus Georgia 31904 —
Urology Enterprises Marietta Georgia 30060 —
Harbin Clinic Department of Urology Research Rome Georgia 30165 —
North Fulton Urology Roswell Georgia 30076 —
St. Joseph's, Candler Health System Savannah Georgia 31405 —
North Idaho Urology Coeur d'Alene Idaho 83814 —
Prairie Medical Associates Chicago Illinois 60616 —
Medical and Surgical Specialists Galesburg Illinois 61401 —
Special Care Research Peoria Illinois 61614 —
Urology of Indiana, LLC Greenwood Indiana 46143 —
MMPC Urology Greenwood Indiana 49546 —
Metropolitan Urology Jeffersonville Indiana 47130 —
Heartland Research Associates, LLC Wichita Kansas 67207 —
LSUHSC/Stanley Scott Cancer Center New Orleans Louisiana 70112 —
Regional Urology LLC Shreveport Louisiana 71106 —
Anne Arundel Urology P.A. Annapolis Maryland 21401 —
Maryland Prostate Center: University of Maryland Medical Center Baltimore Maryland 21201 —
Urology Center, PA Hagerstown Maryland 21742 —
Mid Atlantic Clinical Research Rockville Maryland 28050 —
The Fallon Clinic Worcester Massachusetts 01605 —
Wayne Glazier Worcester Massachusetts 01605 —
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan 48109 —
Beaumont Medical Royal Oak Michigan 48073 —
Mayo Clinic Urology Department Rochester Minnesota 55905 —
Park Nicollet Urology Saint Louis Park Minnesota 55416 —
Kansas City Urology, PC Kansas City Missouri 64131 —
PPS Clinical Research St Louis Missouri 63141 —
Urologic Research Center St Louis Missouri 63141 —
Sheldon Freeman Las Vegas Nevada 89109 —
Urologic Surgeons, Ltd. Reno Nevada 89502 —
Coastal Urology Associates Brick New Jersey 08724 —
Hamilton Urology PA Hamilton New Jersey 08690 —
Lawrenceville Urology Associates Lawrenceville New Jersey 08648 —
Assoc. Urologic Specialists Marlton New Jersey 08053 —
Urology Healthcare Associates Willingboro New Jersey 08046 —
Urology Group of New Mexico Albuquerque New Mexico 87109 —
Urology Inst. Of New York Albany New York 12208 —
William Oberheim Albany New York 12208 —
Metropolitan Urologic Services, PC Elmont New York 11003 —
Urological Surgeons of Long Island Garden City New York 11530 —
University Urology Associates New York New York 10016 —
Mount Sinai School of Medicine New York New York 10029 —
CNY Urology Oneida New York 13421 —
Staten Island Urological Research , PC Staten Island New York 10304 —
Associated Urologists of CNY Syracuse New York 13210 —
Center for Urologic Research WNY, LLC Williamsville New York 14221 —
Asheboro Urology Asheboro North Carolina 27203 —
University of North Carolina Chapel Hill North Carolina 27559 —
The Urology Center Greensboro North Carolina 27403 —
Wake Urology Raleigh North Carolina 27607 —
Piedmont Medical Research Associates Winston-Salem North Carolina 27103 —
Odyssey Research Bismarck North Dakota 58501 —
Summa Health Care Akron Ohio 44304 —
The Urology Group Cincinnati Ohio 45212 —
Cleveland Clinic Lerner College of Medicine Cleveland Ohio 44195 —
Colombus Urology Research Columbus Ohio 43214 —
Urology of Northern Ohio Elyria Ohio 44035 —
Southwest Urology Parma Ohio 44129 —
Oklahoma University Medical Center Oklahoma City Oklahoma 73104 —
Urologic Specialists of Oklahoma, Inc. Tulsa Oklahoma 12208 —
The Corvallis Clinic Corvallis Oregon 97330 —
Oregon Urology Specialists Springfield Oregon 97477 —
Urologic Associates of Allentown Allentown Pennsylvania 18103 —
Urologic Surgery Bala-Cynwyd Pennsylvania 19004 —
Urological Associates of Lancaster, Ltd. Lancaster Pennsylvania 17604 —
The Urology Institute Monroeville Pennsylvania 15146 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Ginsberg and Harkaway Urology Philadelphia Pennsylvania 19141 —
University of Pittsburgh Pittsburgh Pennsylvania 15232 —
State College Urologic Association State College Pennsylvania 16801 —
University Urological Research Institute Providence Rhode Island 02904 —
Radiant Research Greer South Carolina 29651 —
Carolina Urologic Research Center Myrtle Beach South Carolina 29572 —
Volunteer Research Group Knoxville Tennessee 37920 —
Southeast Urology Network Memphis Tennessee 38119 —
Ace Research Specialists Nashville Tennessee 37203 —
Center for Urological Treatment Nashville Tennessee 37203 —
Urology Associates Nashville Tennessee 37209 —
Vanderbilt Medical Center Nashville Tennessee 37232 —
Professional Quality Research Austin Texas 78756 —
Breco Research Houston Texas 77024 —
Urology Consultants, PA San Antonio Texas 78229 —
Urology San Antonio Research, PA San Antonio Texas 78229 —
Scott and White Clinical Hospital Temple Texas 76508 —
Salt Lake City Research Salt Lake City Utah 84124 —
Adult and Pediatric Urologists of Northern VA Alexandria Virginia 22304 —
Devine Tidewater Urology Norfolk Virginia 23502 —
Med Atlantic, Inc (Virginia Urology) Richmond Virginia 23235 —
McGuire VA Medical Center Richmond Virginia 23249 —
Seattle VAMC Seattle Washington 98108 —
Deaconess Medical Center Spokane Washington 99204 —
Madigan Army Medical Center Tacoma Washington 98431 —
University of Wisconsin Medical School: Clinical Trials Madison Wisconsin 53715 —
St. Michael's Hospital Milwaukee Wisconsin 53209 —
Froedtert Memorial Lutheran Hospital Department of Urology Milwaukee Wisconsin 53226 —
Wyoming Research Foundation Cheyenne Wyoming 82001 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00129142, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 15, 2013 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00129142 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →