Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy
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
1 other identifier
interventional
1,200
2 countries
155
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Oct 2003
155 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 9, 2005
CompletedFirst Posted
Study publicly available on registry
August 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedNovember 15, 2013
November 1, 2013
4.1 years
August 9, 2005
November 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of subjects at 24 months with at least one new vertebral fracture determined by blinded central review of radiographs of the thoracic and lumbar spine
Secondary Outcomes (3)
Percentage of subjects with at least one new or worsening vertebral fracture at 24 months
Percentage of subjects with a clinical fragility fracture at 12 and 24 months
Percent change from baseline in lumbar bone mineral density (BMD) as measured by dual energy x-ray absorptiometry (DEXA) scan at 24 months
Interventions
Eligibility Criteria
You may qualify if:
- Give voluntary, signed informed consent in accordance with institutional policies
- Be male, aged ≥ 50 years
You may not qualify if:
- Have been on:
- ADT treatment (either luteinizing hormone-releasing agonist \[LHRHa\] or orchiectomy) for at least 6 months; Or
- Intermittent LHRHa for at least the preceding 12 months is acceptable, but subjects must be maintained on uninterrupted treatment for the duration of this study once they are randomized into the study.
- Be aged ≥ 70 years or have BMD of lumbar spine or femoral neck at or below the specified thresholds for study entry:
- Hologic BMD (g/cm2): L1-L4 - 0.926; Femoral neck - 0.717
- Lunar BMD (g/cm2): L1-L4 - 1.050; Femoral neck - 0.840
- Serum prostate-specific antigen (PSA) ≤ 4 ng/mL
- Have a Zubrod performance status ≤ 1
- Subject weight \< 300 lbs (weight limitation of DEXA equipment)
- Agree to complete a daily diary of medication intake and to provide tablet containers for accurate counts
- Agree to use an effective method of contraception, if the partner is of childbearing age, while on study
- Have adequate bone marrow, liver and renal function:
- White blood cell (WBC) count ≥ 3,000/mm3;
- Platelet count ≥ 100,000/mm3;
- Bilirubin ≤ 1.5 mg/dL;
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GTxlead
Study Sites (155)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Coastal Clinical Research
Mobile, Alabama, 36608, United States
Arkansas Urology
Little Rock, Arkansas, 72211, United States
Advanced Urology Medical Center Clinical Trials
Anaheim, California, 92801, United States
Urological Sciences Research Foudation
Culver City, California, 90232, United States
Urological Associates of Central CA
Fresno, California, 93720, United States
Center of Urologic Research
La Mesa, California, 91942, United States
South Orange County Medical Research Center
Laguna Woods, California, 92653, United States
Palo Alto VA
Palo Alto, California, 94305, United States
San Bernadino Urological Associates
San Bernadino, California, 92404, United States
Urological Physicians of San Diego
San Diego, California, 92103, United States
Veterans Medical Research Foundation
San Diego, California, 92161, United States
Pacific Clinical Research
Santa Monica, California, 90404, United States
West Coast Clinical Research
Tarzana, California, 91356, United States
Western Clinical Research, Inc.
Torrance, California, 90505, United States
Urology Associates
Denver, Colorado, 80210, United States
Western Urological Research
Wheat Ridge, Colorado, 80033, United States
Urologic Center
New Haven, Connecticut, 06511, United States
Urological Associates of Bridgeport
Trumball, Connecticut, 06611, United States
Connecticut Clinical Research
Waterbury, Connecticut, 06708, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Urology Consultants Inc.
Clearwater, Florida, 33761, United States
Atlantic Urological Associates
Daytona Beach, Florida, 32114, United States
Urosearch
Inverness, Florida, 34452, United States
Lakeland Regional Medical Center
Lakeland, Florida, 33805, United States
Advance Research Institute
New Port Richey, Florida, 34652, United States
Central Florida Urology Group/ UroSearch
Ocala, Florida, 34474, United States
Florida Foundation for Healthcare Research
Ocala, Florida, 34474, United States
Winter Park Urology Associates
Orlando, Florida, 32803, United States
Panama City Urology
Panama City Beach, Florida, 32405, United States
Pinellas Urology
St. Petersburg, Florida, 33710, United States
Southeastern Research Group
Tallahassee, Florida, 32308, United States
Tampa Bay Urology
Tampa, Florida, 33607, United States
UroSearch
Tavares, Florida, 32778, United States
Cleveland Clinic-Florida
Weston, Florida, 33331, United States
Midtown Urology
Atlanta, Georgia, 30308, United States
Georgia Urology
Atlanta, Georgia, 30342, United States
St. Joseph Research Institute
Atlanta, Georgia, 30342, United States
Augusta VAMC
Augusta, Georgia, 30912, United States
Southeastern Medical Research Institute
Columbus, Georgia, 31904, United States
Urology Enterprises
Marietta, Georgia, 30060, United States
Harbin Clinic Department of Urology Research
Rome, Georgia, 30165, United States
North Fulton Urology
Roswell, Georgia, 30076, United States
St. Joseph's, Candler Health System
Savannah, Georgia, 31405, United States
North Idaho Urology
Coeur d'Alene, Idaho, 83814, United States
Prairie Medical Associates
Chicago, Illinois, 60616, United States
Medical and Surgical Specialists
Galesburg, Illinois, 61401, United States
Special Care Research
Peoria, Illinois, 61614, United States
Urology of Indiana, LLC
Greenwood, Indiana, 46143, United States
MMPC Urology
Greenwood, Indiana, 49546, United States
Metropolitan Urology
Jeffersonville, Indiana, 47130, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
LSUHSC/Stanley Scott Cancer Center
New Orleans, Louisiana, 70112, United States
Regional Urology LLC
Shreveport, Louisiana, 71106, United States
Anne Arundel Urology P.A.
Annapolis, Maryland, 21401, United States
Maryland Prostate Center: University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Urology Center, PA
Hagerstown, Maryland, 21742, United States
Mid Atlantic Clinical Research
Rockville, Maryland, 28050, United States
The Fallon Clinic
Worcester, Massachusetts, 01605, United States
Wayne Glazier
Worcester, Massachusetts, 01605, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Beaumont Medical
Royal Oak, Michigan, 48073, United States
Mayo Clinic Urology Department
Rochester, Minnesota, 55905, United States
Park Nicollet Urology
Saint Louis Park, Minnesota, 55416, United States
Kansas City Urology, PC
Kansas City, Missouri, 64131, United States
PPS Clinical Research
St Louis, Missouri, 63141, United States
Urologic Research Center
St Louis, Missouri, 63141, United States
Sheldon Freeman
Las Vegas, Nevada, 89109, United States
Urologic Surgeons, Ltd.
Reno, Nevada, 89502, United States
Coastal Urology Associates
Brick, New Jersey, 08724, United States
Hamilton Urology PA
Hamilton, New Jersey, 08690, United States
Lawrenceville Urology Associates
Lawrenceville, New Jersey, 08648, United States
Assoc. Urologic Specialists
Marlton, New Jersey, 08053, United States
Urology Healthcare Associates
Willingboro, New Jersey, 08046, United States
Urology Group of New Mexico
Albuquerque, New Mexico, 87109, United States
Urology Inst. Of New York
Albany, New York, 12208, United States
William Oberheim
Albany, New York, 12208, United States
Metropolitan Urologic Services, PC
Elmont, New York, 11003, United States
Urological Surgeons of Long Island
Garden City, New York, 11530, United States
University Urology Associates
New York, New York, 10016, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
CNY Urology
Oneida, New York, 13421, United States
Staten Island Urological Research , PC
Staten Island, New York, 10304, United States
Associated Urologists of CNY
Syracuse, New York, 13210, United States
Center for Urologic Research WNY, LLC
Williamsville, New York, 14221, United States
Asheboro Urology
Asheboro, North Carolina, 27203, United States
University of North Carolina
Chapel Hill, North Carolina, 27559, United States
The Urology Center
Greensboro, North Carolina, 27403, United States
Wake Urology
Raleigh, North Carolina, 27607, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
Odyssey Research
Bismarck, North Dakota, 58501, United States
Summa Health Care
Akron, Ohio, 44304, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, 44195, United States
Colombus Urology Research
Columbus, Ohio, 43214, United States
Urology of Northern Ohio
Elyria, Ohio, 44035, United States
Southwest Urology
Parma, Ohio, 44129, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104, United States
Urologic Specialists of Oklahoma, Inc.
Tulsa, Oklahoma, 12208, United States
The Corvallis Clinic
Corvallis, Oregon, 97330, United States
Oregon Urology Specialists
Springfield, Oregon, 97477, United States
Urologic Associates of Allentown
Allentown, Pennsylvania, 18103, United States
Urologic Surgery
Bala-Cynwyd, Pennsylvania, 19004, United States
Urological Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, 17604, United States
The Urology Institute
Monroeville, Pennsylvania, 15146, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Ginsberg and Harkaway Urology
Philadelphia, Pennsylvania, 19141, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
State College Urologic Association
State College, Pennsylvania, 16801, United States
University Urological Research Institute
Providence, Rhode Island, 02904, United States
Radiant Research
Greer, South Carolina, 29651, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, United States
Southeast Urology Network
Memphis, Tennessee, 38119, United States
Ace Research Specialists
Nashville, Tennessee, 37203, United States
Center for Urological Treatment
Nashville, Tennessee, 37203, United States
Urology Associates
Nashville, Tennessee, 37209, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37232, United States
Professional Quality Research
Austin, Texas, 78756, United States
Breco Research
Houston, Texas, 77024, United States
Urology Consultants, PA
San Antonio, Texas, 78229, United States
Urology San Antonio Research, PA
San Antonio, Texas, 78229, United States
Scott and White Clinical Hospital
Temple, Texas, 76508, United States
Salt Lake City Research
Salt Lake City, Utah, 84124, United States
Adult and Pediatric Urologists of Northern VA
Alexandria, Virginia, 22304, United States
Devine Tidewater Urology
Norfolk, Virginia, 23502, United States
Med Atlantic, Inc (Virginia Urology)
Richmond, Virginia, 23235, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Seattle VAMC
Seattle, Washington, 98108, United States
Deaconess Medical Center
Spokane, Washington, 99204, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
University of Wisconsin Medical School: Clinical Trials
Madison, Wisconsin, 53715, United States
St. Michael's Hospital
Milwaukee, Wisconsin, 53209, United States
Froedtert Memorial Lutheran Hospital Department of Urology
Milwaukee, Wisconsin, 53226, United States
Wyoming Research Foundation
Cheyenne, Wyoming, 82001, United States
American British Cowdray Hospital
Mexico City, D. F, 01120, Mexico
Centro Medico Dalinde
Mexico City, D. F, 06760, Mexico
Hospital General de Mexico
Mexico City, D. F, 06760, Mexico
Hospital Regional "Gabriel Mancera", IMSS
Mexico City, D.f,, Mexico
Centro Medico Naval
Mexico City, D.f., 01090, Mexico
Hospital General de Zona No. 1-A
Mexico City, D.f., 03300, Mexico
Clinica Londres
Mexico City, D.f., 06760, Mexico
Hospital Central Militar, SDN
Mexico City, D.f., 11649, Mexico
Hospital Medica Sur
Mexico City, D.f., 14050, 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, 07300, Mexico
Hospital Civil Viejo "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44280, Mexico
Centro Medico de Occidente-IMSS
Guadalajara, Jalisco, 44340, Mexico
Hospital Regional Dr Valentin Gomez Farias, ISSSTE
Guadalajara, Jalisco, Mexico
Hospital Regional de Especialidades
Monterrey, N.l., 64320, Mexico
Hospital Universitario
Monterrey, N.l., 64460, Mexico
Hospital Ignacio Morones Prieto
San Luis Potosí City, S.l.p., 78240, Mexico
Hospital General de Zona con UMF No. 2 San Luis Potosi
San Luis Potosí City, S.l.p., 78270, Mexico
Related Publications (2)
Smith MR, Morton RA, Barnette KG, Sieber PR, Malkowicz SB, Rodriguez D, Hancock ML, Steiner MS. Toremifene to reduce fracture risk in men receiving androgen deprivation therapy for prostate cancer. J Urol. 2013 Jan;189(1 Suppl):S45-50. doi: 10.1016/j.juro.2012.11.016.
PMID: 23234631DERIVEDMorgans AK, Hancock ML, Barnette KG, Steiner MS, Morton RA, Smith MR. Racial differences in bone mineral density and fractures in men receiving androgen deprivation therapy for prostate cancer. J Urol. 2012 Mar;187(3):889-93. doi: 10.1016/j.juro.2011.10.136. Epub 2012 Jan 15.
PMID: 22245322DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mitchell Steiner, M.D.
GTx
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 9, 2005
First Posted
August 11, 2005
Study Start
October 1, 2003
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
November 15, 2013
Record last verified: 2013-11