Spots Global Cancer Trial Database for Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy
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Trial Identification
Brief Title: Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy
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
Study ID: NCT00129142
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Urology Centers of Alabama, Homewood, Alabama, United States
Coastal Clinical Research, Mobile, Alabama, United States
Arkansas Urology, Little Rock, Arkansas, United States
Advanced Urology Medical Center Clinical Trials, Anaheim, California, United States
Urological Sciences Research Foudation, Culver City, California, United States
Urological Associates of Central CA, Fresno, California, United States
Center of Urologic Research, La Mesa, California, United States
South Orange County Medical Research Center, Laguna Woods, California, United States
Palo Alto VA, Palo Alto, California, United States
San Bernadino Urological Associates, San Bernadino, California, United States
Urological Physicians of San Diego, San Diego, California, United States
Veterans Medical Research Foundation, San Diego, California, United States
Pacific Clinical Research, Santa Monica, California, United States
West Coast Clinical Research, Tarzana, California, United States
Western Clinical Research, Inc., Torrance, California, United States
Urology Associates, Denver, Colorado, United States
Western Urological Research, Wheat Ridge, Colorado, United States
Urologic Center, New Haven, Connecticut, United States
Urological Associates of Bridgeport, Trumball, Connecticut, United States
Connecticut Clinical Research, Waterbury, Connecticut, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
South Florida Medical Research, Aventura, Florida, United States
Urology Consultants Inc., Clearwater, Florida, United States
Atlantic Urological Associates, Daytona Beach, Florida, United States
Urosearch, Inverness, Florida, United States
Lakeland Regional Medical Center, Lakeland, Florida, United States
Advance Research Institute, New Port Richey, Florida, United States
Central Florida Urology Group/ UroSearch, Ocala, Florida, United States
Florida Foundation for Healthcare Research, Ocala, Florida, United States
Winter Park Urology Associates, Orlando, Florida, United States
Panama City Urology, Panama City Beach, Florida, United States
Pinellas Urology, St. Petersburg, Florida, United States
Southeastern Research Group, Tallahassee, Florida, United States
Tampa Bay Urology, Tampa, Florida, United States
UroSearch, Tavares, Florida, United States
Cleveland Clinic-Florida, Weston, Florida, United States
Midtown Urology, Atlanta, Georgia, United States
Georgia Urology, Atlanta, Georgia, United States
St. Joseph Research Institute, Atlanta, Georgia, United States
Augusta VAMC, Augusta, Georgia, United States
Southeastern Medical Research Institute, Columbus, Georgia, United States
Urology Enterprises, Marietta, Georgia, United States
Harbin Clinic Department of Urology Research, Rome, Georgia, United States
North Fulton Urology, Roswell, Georgia, United States
St. Joseph's, Candler Health System, Savannah, Georgia, United States
North Idaho Urology, Coeur d'Alene, Idaho, United States
Prairie Medical Associates, Chicago, Illinois, United States
Medical and Surgical Specialists, Galesburg, Illinois, United States
Special Care Research, Peoria, Illinois, United States
Urology of Indiana, LLC, Greenwood, Indiana, United States
MMPC Urology, Greenwood, Indiana, United States
Metropolitan Urology, Jeffersonville, Indiana, United States
Heartland Research Associates, LLC, Wichita, Kansas, United States
LSUHSC/Stanley Scott Cancer Center, New Orleans, Louisiana, United States
Regional Urology LLC, Shreveport, Louisiana, United States
Anne Arundel Urology P.A., Annapolis, Maryland, United States
Maryland Prostate Center: University of Maryland Medical Center, Baltimore, Maryland, United States
Urology Center, PA, Hagerstown, Maryland, United States
Mid Atlantic Clinical Research, Rockville, Maryland, United States
The Fallon Clinic, Worcester, Massachusetts, United States
Wayne Glazier, Worcester, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Beaumont Medical, Royal Oak, Michigan, United States
Mayo Clinic Urology Department, Rochester, Minnesota, United States
Park Nicollet Urology, St. Louis Park, Minnesota, United States
Kansas City Urology, PC, Kansas, Missouri, United States
PPS Clinical Research, St Louis, Missouri, United States
Urologic Research Center, St. Louis, Missouri, United States
Sheldon Freeman, Las Vegas, Nevada, United States
Urologic Surgeons, Ltd., Reno, Nevada, United States
Coastal Urology Associates, Brick, New Jersey, United States
Hamilton Urology PA, Hamilton, New Jersey, United States
Lawrenceville Urology Associates, Lawrenceville, New Jersey, United States
Assoc. Urologic Specialists, Marlton, New Jersey, United States
Urology Healthcare Associates, Willingboro, New Jersey, United States
Urology Group of New Mexico, Albuquerque, New Mexico, United States
Urology Inst. Of New York, Albany, New York, United States
William Oberheim, Albany, New York, United States
Metropolitan Urologic Services, PC, Elmont, New York, United States
Urological Surgeons of Long Island, Garden City, New York, United States
University Urology Associates, New York, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
CNY Urology, Oneida, New York, United States
Staten Island Urological Research , PC, Staten Island, New York, United States
Associated Urologists of CNY, Syracuse, New York, United States
Center for Urologic Research WNY, LLC, Williamsville, New York, United States
Asheboro Urology, Asheboro, North Carolina, United States
University of North Carolina, Chapel Hill, North Carolina, United States
The Urology Center, Greensboro, North Carolina, United States
Wake Urology, Raleigh, North Carolina, United States
Piedmont Medical Research Associates, Winston-Salem, North Carolina, United States
Odyssey Research, Bismarck, North Dakota, United States
Summa Health Care, Akron, Ohio, United States
The Urology Group, Cincinnati, Ohio, United States
Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, United States
Colombus Urology Research, Columbus, Ohio, United States
Urology of Northern Ohio, Elyria, Ohio, United States
Southwest Urology, Parma, Ohio, United States
Oklahoma University Medical Center, Oklahoma City, Oklahoma, United States
Urologic Specialists of Oklahoma, Inc., Tulsa, Oklahoma, United States
The Corvallis Clinic, Corvallis, Oregon, United States
Oregon Urology Specialists, Springfield, Oregon, United States
Urologic Associates of Allentown, Allentown, Pennsylvania, United States
Urologic Surgery, Bala Cynwyd, Pennsylvania, United States
Urological Associates of Lancaster, Ltd., Lancaster, Pennsylvania, United States
The Urology Institute, Monroeville, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Ginsberg and Harkaway Urology, Philadelphia, Pennsylvania, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
State College Urologic Association, State College, Pennsylvania, United States
University Urological Research Institute, Providence, Rhode Island, United States
Radiant Research, Greer, South Carolina, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Volunteer Research Group, Knoxville, Tennessee, United States
Southeast Urology Network, Memphis, Tennessee, United States
Ace Research Specialists, Nashville, Tennessee, United States
Center for Urological Treatment, Nashville, Tennessee, United States
Urology Associates, Nashville, Tennessee, United States
Vanderbilt Medical Center, Nashville, Tennessee, United States
Professional Quality Research, Austin, Texas, United States
Breco Research, Houston, Texas, United States
Urology Consultants, PA, San Antonio, Texas, United States
Urology San Antonio Research, PA, San Antonio, Texas, United States
Scott and White Clinical Hospital, Temple, Texas, United States
Salt Lake City Research, Salt Lake City, Utah, United States
Adult and Pediatric Urologists of Northern VA, Alexandria, Virginia, United States
Devine Tidewater Urology, Norfolk, Virginia, United States
Med Atlantic, Inc (Virginia Urology), Richmond, Virginia, United States
McGuire VA Medical Center, Richmond, Virginia, United States
Seattle VAMC, Seattle, Washington, United States
Deaconess Medical Center, Spokane, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
University of Wisconsin Medical School: Clinical Trials, Madison, Wisconsin, United States
St. Michael's Hospital, Milwaukee, Wisconsin, United States
Froedtert Memorial Lutheran Hospital Department of Urology, Milwaukee, Wisconsin, United States
Wyoming Research Foundation, Cheyenne, Wyoming, United States
American British Cowdray Hospital, Mexico City, D. F, Mexico
Centro Medico Dalinde, Mexico City, D. F, Mexico
Hospital General de Mexico, Mexico City, D. F, Mexico
Hospital Regional "Gabriel Mancera", IMSS, Mexico City, D.f,, Mexico
Centro Medico Naval, Mexico City, D.f., Mexico
Hospital General de Zona No. 1-A, Mexico City, D.f., Mexico
Clinica Londres, Mexico City, D.f., Mexico
Hospital Central Militar, SDN, Mexico City, D.f., Mexico
Hospital Medica Sur, Mexico City, D.f., Mexico
Hospital de Oncologia CMN Siglo XXI, IMSS, Mexico City, D.f., Mexico
Hospital General de Zona No. 26, Mexico D.F., Mexico City, D.f., Mexico
Hospital General Region 1 de Octubre, ISSSTE, Mexico City, D.F, Mexico
Hospital Civil Viejo "Fray Antonio Alcalde", Guadalajara, Jal, Mexico
Centro Medico de Occidente-IMSS, Guadalajara, Jal, Mexico
Hospital Regional Dr Valentin Gomez Farias, ISSSTE, Guadalajara, Jal, Mexico
Hospital Regional de Especialidades, Monterrey, N.l., Mexico
Hospital Universitario, Monterrey, N.l., Mexico
Hospital Ignacio Morones Prieto, San Luis Potosi, S.l.p., Mexico
Hospital General de Zona con UMF No. 2 San Luis Potosi, San Luis Potosi, S.l.p., Mexico
Contact Details
Name: Mitchell Steiner, M.D.
Affiliation: GTx
Role: STUDY_DIRECTOR
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