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

November 13, 2013 updated by: GTx

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • D. F
      • Mexico City, D. F, Mexico, 01120
        • American British Cowdray Hospital
      • Mexico City, D. F, Mexico, 06760
        • Centro Medico Dalinde
      • Mexico City, D. F, Mexico, 06760
        • Hospital General De Mexico
    • D.F
      • Mexico City, D.F, Mexico, 07300
        • Hospital General Region 1 de Octubre, ISSSTE
    • D.f,
      • Mexico City, D.f,, Mexico
        • Hospital Regional "Gabriel Mancera", IMSS
    • D.f.
      • Mexico City, D.f., Mexico, 01090
        • Centro Medico Naval
      • Mexico City, D.f., Mexico, 03300
        • Hospital General de Zona No. 1-A
      • Mexico City, D.f., Mexico, 06760
        • Clinica Londres
      • Mexico City, D.f., Mexico, 11649
        • Hospital Central Militar, SDN
      • Mexico City, D.f., Mexico, 14050
        • 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.
    • Jal
      • Guadalajara, Jal, Mexico, 44280
        • Hospital Civil Viejo "Fray Antonio Alcalde"
      • Guadalajara, Jal, Mexico, 44340
        • Centro Medico de Occidente-IMSS
      • Guadalajara, Jal, Mexico
        • Hospital Regional Dr Valentin Gomez Farias, ISSSTE
    • N.l.
      • Monterrey, N.l., Mexico, 64320
        • Hospital Regional de Especialidades
      • Monterrey, N.l., Mexico, 64460
        • Hospital Universitario
    • S.l.p.
      • San Luis Potosi, S.l.p., Mexico, 78240
        • Hospital Ignacio Morones Prieto
      • San Luis Potosi, S.l.p., Mexico, 78270
        • Hospital General de Zona con UMF No. 2 San Luis Potosi
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Urology
    • California
      • Anaheim, California, United States, 92801
        • Advanced Urology Medical Center Clinical Trials
      • Culver City, California, United States, 90232
        • Urological Sciences Research Foudation
      • Fresno, California, United States, 93720
        • Urological Associates of Central CA
      • La Mesa, California, United States, 91942
        • Center of Urologic Research
      • Laguna Woods, California, United States, 92653
        • South Orange County Medical Research Center
      • Palo Alto, California, United States, 94305
        • Palo Alto VA
      • San Bernadino, California, United States, 92404
        • San Bernadino Urological Associates
      • San Diego, California, United States, 92161
        • Veterans Medical Research Foundation
      • San Diego, California, United States, 92103
        • Urological Physicians of San Diego
      • Santa Monica, California, United States, 90404
        • Pacific Clinical Research
      • Tarzana, California, United States, 91356
        • West Coast Clinical Research
      • Torrance, California, United States, 90505
        • Western Clinical Research, Inc.
    • Colorado
      • Denver, Colorado, United States, 80210
        • Urology Associates
      • Wheat Ridge, Colorado, United States, 80033
        • Western Urological Research
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Urologic Center
      • Trumball, Connecticut, United States, 06611
        • Urological Associates of Bridgeport
      • Waterbury, Connecticut, United States, 06708
        • Connecticut Clinical Research
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Walter Reed Army Medical Center
    • Florida
      • Aventura, Florida, United States, 33180
        • South Florida Medical Research
      • Clearwater, Florida, United States, 33761
        • Urology Consultants Inc.
      • Daytona Beach, Florida, United States, 32114
        • Atlantic Urological Associates
      • Inverness, Florida, United States, 34452
        • UroSearch
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Medical Center
      • New Port Richey, Florida, United States, 34652
        • Advance Research Institute
      • Ocala, Florida, United States, 34474
        • Florida Foundation for Healthcare Research
      • Ocala, Florida, United States, 34474
        • Central Florida Urology Group/ UroSearch
      • Orlando, Florida, United States, 32803
        • Winter Park Urology Associates
      • Panama City Beach, Florida, United States, 32405
        • Panama City Urology
      • St. Petersburg, Florida, United States, 33710
        • Pinellas Urology
      • Tallahassee, Florida, United States, 32308
        • Southeastern Research Group
      • Tampa, Florida, United States, 33607
        • Tampa Bay Urology
      • Tavares, Florida, United States, 32778
        • UroSearch
      • Weston, Florida, United States, 33331
        • Cleveland Clinic-Florida
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Midtown Urology
      • Atlanta, Georgia, United States, 30342
        • Georgia Urology
      • Atlanta, Georgia, United States, 30342
        • St. Joseph Research Institute
      • Augusta, Georgia, United States, 30912
        • Augusta VAMC
      • Columbus, Georgia, United States, 31904
        • Southeastern Medical Research Institute
      • Marietta, Georgia, United States, 30060
        • Urology Enterprises
      • Rome, Georgia, United States, 30165
        • Harbin Clinic Department of Urology Research
      • Roswell, Georgia, United States, 30076
        • North Fulton Urology
      • Savannah, Georgia, United States, 31405
        • St. Joseph's, Candler Health System
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • North Idaho Urology
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Prairie Medical Associates
      • Galesburg, Illinois, United States, 61401
        • Medical and Surgical Specialists
      • Peoria, Illinois, United States, 61614
        • Special Care Research
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Urology of Indiana, LLC
      • Greenwood, Indiana, United States, 49546
        • MMPC Urology
      • Jeffersonville, Indiana, United States, 47130
        • Metropolitan Urology
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSUHSC/Stanley Scott Cancer Center
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology LLC
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Urology P.A.
      • Baltimore, Maryland, United States, 21201
        • Maryland Prostate Center: University of Maryland Medical Center
      • Hagerstown, Maryland, United States, 21742
        • Urology Center, PA
      • Rockville, Maryland, United States, 28050
        • Mid Atlantic Clinical Research
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • The Fallon Clinic
      • Worcester, Massachusetts, United States, 01605
        • Wayne Glazier
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Medical
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Urology Department
      • St. Louis Park, Minnesota, United States, 55416
        • Park Nicollet Urology
    • Missouri
      • Kansas, Missouri, United States, 64131
        • Kansas City Urology, PC
      • St Louis, Missouri, United States, 63141
        • PPS Clinical Research
      • St. Louis, Missouri, United States, 63141
        • Urologic Research Center
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Sheldon Freeman
      • Reno, Nevada, United States, 89502
        • Urologic Surgeons, Ltd.
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Coastal Urology Associates
      • Hamilton, New Jersey, United States, 08690
        • Hamilton Urology PA
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrenceville Urology Associates
      • Marlton, New Jersey, United States, 08053
        • Assoc. Urologic Specialists
      • Willingboro, New Jersey, United States, 08046
        • Urology Healthcare Associates
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Urology Group of New Mexico
    • New York
      • Albany, New York, United States, 12208
        • Urology Inst. Of New York
      • Albany, New York, United States, 12208
        • William Oberheim
      • Elmont, New York, United States, 11003
        • Metropolitan Urologic Services, PC
      • Garden City, New York, United States, 11530
        • Urological Surgeons of Long Island
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10016
        • University Urology Associates
      • Oneida, New York, United States, 13421
        • CNY Urology
      • Staten Island, New York, United States, 10304
        • Staten Island Urological Research , PC
      • Syracuse, New York, United States, 13210
        • Associated Urologists of CNY
      • Williamsville, New York, United States, 14221
        • Center for Urologic Research WNY, LLC
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Asheboro Urology
      • Chapel Hill, North Carolina, United States, 27559
        • University of North Carolina
      • Greensboro, North Carolina, United States, 27403
        • The Urology Center
      • Raleigh, North Carolina, United States, 27607
        • Wake Urology
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research Associates
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Odyssey Research
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health Care
      • Cincinnati, Ohio, United States, 45212
        • The Urology Group
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Lerner College of Medicine
      • Columbus, Ohio, United States, 43214
        • Colombus Urology Research
      • Elyria, Ohio, United States, 44035
        • Urology of Northern Ohio
      • Parma, Ohio, United States, 44129
        • Southwest Urology
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center
      • Tulsa, Oklahoma, United States, 12208
        • Urologic Specialists of Oklahoma, Inc.
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • The Corvallis Clinic
      • Springfield, Oregon, United States, 97477
        • Oregon Urology Specialists
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Urologic Associates of Allentown
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Urologic Surgery
      • Lancaster, Pennsylvania, United States, 17604
        • Urological Associates of Lancaster, Ltd.
      • Monroeville, Pennsylvania, United States, 15146
        • The Urology Institute
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Ginsberg and Harkaway Urology
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh
      • State College, Pennsylvania, United States, 16801
        • State College Urologic Association
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • University Urological Research Institute
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Radiant Research
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Volunteer Research Group
      • Memphis, Tennessee, United States, 38119
        • Southeast Urology Network
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Medical Center
      • Nashville, Tennessee, United States, 37209
        • Urology Associates
      • Nashville, Tennessee, United States, 37203
        • Center for Urological Treatment
      • Nashville, Tennessee, United States, 37203
        • Ace Research Specialists
    • Texas
      • Austin, Texas, United States, 78756
        • Professional Quality Research
      • Houston, Texas, United States, 77024
        • Breco Research
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research, PA
      • San Antonio, Texas, United States, 78229
        • Urology Consultants, PA
      • Temple, Texas, United States, 76508
        • Scott and White Clinical Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Salt Lake City Research
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Adult and Pediatric Urologists of Northern VA
      • Norfolk, Virginia, United States, 23502
        • Devine Tidewater Urology
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical Center
      • Richmond, Virginia, United States, 23235
        • Med Atlantic, Inc (Virginia Urology)
    • Washington
      • Seattle, Washington, United States, 98108
        • Seattle VAMC
      • Spokane, Washington, United States, 99204
        • Deaconess Medical Center
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • University of Wisconsin Medical School: Clinical Trials
      • Milwaukee, Wisconsin, United States, 53209
        • St. Michael's Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Memorial Lutheran Hospital Department of Urology
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Wyoming Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

To be eligible for participation in this study, subjects must meet all of the following criteria (minor deviations may be discussed with the medical monitor for possible inclusions):

  • Give voluntary, signed informed consent in accordance with institutional policies
  • Be male, aged ≥ 50 years
  • Have histologically documented prostate cancer. Subjects with metastatic prostate cancer may still be considered for the study as long as they are not disqualified by other inclusion/exclusion criteria and there is a reasonable expectation that their medical condition will not interfere with the objectives of the study and that adequate follow-up and compliance with the study protocol can be achieved for the full 24-month duration of the study.

  • 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;
    • AST and ALT < 2x upper limit of normal;
    • Serum creatinine ≤ 2.0 mg%.

Exclusion Criteria:

Subjects with any of the following will not be eligible for enrollment:

  • Taking bisphosphonates, selective estrogen receptor modulators (SERMs), parathyroid hormone (PTH), Forteo® (teriparatide), calcitonin, or oral glucocorticoids within 45 days of randomization
  • Have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic and lumbar spine (at least eight evaluable vertebrae in the range T4 to L4) [for example, severe scoliosis, or sequelae of orthopedic procedures or other surgery]
  • Have > 4 vertebral fragility fractures
  • Have any history of other carcinomas within the last 5 years (except nonmelanoma cutaneous malignancies and superficial bladder cancer with no evidence of recurrence which will not be excluded). NOTE: Patients with cancers other than nonmelanoma cutaneous malignancies and superficial bladder cancer with no evidence of tumor recurrence for at least 5 years after definitive treatment will not be excluded from this study.
  • Have Paget's disease of bone
  • Have active systemic viral, bacterial or fungal infections requiring treatment
  • Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol for the full 24-month duration of the study
  • Received treatment with other investigational agents within 30 days prior to randomization
  • Taking finasteride (e.g., Proscar®), dutasteride (e.g., Avodart®), Danocrine® (danazol) or testosterone-like supplements, such as dehydroepiandrosterone (DHEA) [subject is eligible if he stops these agents for a total washout of 45 days prior to randomization and agrees not to use these agents for the duration of the study]
  • Taking herbal medicine or dietary supplements for prostate health, such as PC SPES and saw palmetto (also known as Serenoa repens) [subject is eligible if he stops these agents for a total washout of 45 days prior to randomization and agrees not to use these agents for the duration of the study]. Lycopene and selenium are not prohibited and no washout is required.
  • Have a history of thromboembolic disease including deep vein thrombosis or pulmonary embolus
  • Have a history of chronic hepatitis or cirrhosis
  • Have received prior treatment with toremifene

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GTx

Investigators

  • Study Director: Mitchell Steiner, M.D., GTx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

August 9, 2005

First Submitted That Met QC Criteria

August 9, 2005

First Posted (Estimate)

August 11, 2005

Study Record Updates

Last Update Posted (Estimate)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G300203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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