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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

Phase 3
50 Years
Not Enrolling
Prostate Cancer, Osteoporosis, Fractures

Thank you

Trial Information

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

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

- 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

- 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

- Have a history of chronic hepatitis or cirrhosis

- Have received prior treatment with toremifene

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

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

Principal Investigator

Robert S. Boger, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2003

Completion Date:

November 2007

Related Keywords:

  • Prostate Cancer
  • Osteoporosis
  • Fractures
  • Prostate cancer
  • Bone Loss
  • Osteoporosis
  • Fractures
  • Androgen Deprivation Therapy
  • Fractures, Bone
  • Osteoporosis
  • Prostatic Neoplasms



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
Mount Sinai School of Medicine New York, New York  10029
Deaconess Medical Center Spokane, Washington  99210-0248
Madigan Army Medical Center Tacoma, Washington  98431-5048
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Mid Atlantic Clinical Research Rockville, Maryland  20850
Atlantic Urological Associates Daytona Beach, Florida  32114
Georgia Urology Atlanta, Georgia  30342
San Bernadino Urological Associates San Bernadino, California  92404
Lakeland Regional Medical Center Lakeland, Florida  33804
University of Pittsburgh Pittsburgh, Pennsylvania  15261
Devine Tidewater Urology Norfolk, Virginia  23507
University of North Carolina Chapel Hill, North Carolina  27599
University of Pennsylvania Philadelphia, Pennsylvania  19104
South Florida Medical Research Aventura, Florida  33180
UroSearch Leesburg, Florida  34748
North Idaho Urology Couer D'Alene, Idaho  83814
Pacific Clinical Research Santa Monica, California  90404
Urology of Indiana, LLC Indianapolis, Indiana  46202
Florida Foundation for Healthcare Research Ocala, Florida  34474
Winter Park Urology Associates Orlando, Florida  32803
The Urology Group Cincinnati, Ohio  45212
Southwest Urology Parma, Ohio  44129
Urology Centers Of Alabama Homewood,, Alabama  35205
Western Clinical Research, Inc. Torrance,, California  90505-4763
The Urology Center Greensboro,, North Carolina  27401
Urologic Specialists Of Oklahoma, Inc. Tulsa,, Oklahoma  74104-5433
Oregon Urology Specialists Eugene, Oregon  97401
Urologic Associates of Allentown Allentown, Pennsylvania  18103
Urology Associates Nashville, Tennessee  37209
Wyoming Research Foundation Cheyenne, Wyoming  82001
South Orange County Medical Research Center Laguna Hills, California  92653
Professional Quality Research Austin, Texas  78756
Urological Associates of Lancaster, Ltd. Lancaster, Pennsylvania  17604
University Urological Research Institute Providence, Rhode Island  02904
Heartland Research Associates, LLC Wichita, Kansas  67207
Arkansas Urology Little Rock, Arkansas  72211
Urological Surgeons of Long Island Garden City, New York  11530
McGuire VA Medical Center Richmond, Virginia  23249
Carolina Urologic Research Center Myrtle Beach, South Carolina  29572
Midtown Urology Atlanta, Georgia  30308
Medical and Surgical Specialists Galesburg, Illinois  61401
Metropolitan Urology Jeffersonville, Indiana  47130
Urology Group of New Mexico Albuquerque, New Mexico  87109
Odyssey Research Bismarck, North Dakota  58501
Volunteer Research Group Knoxville, Tennessee  37920
Southeastern Research Group Tallahassee, Florida  32308
Piedmont Medical Research Associates Winston Salem, North Carolina  27103
Vanderbilt Medical Center Nashville, Tennessee  37232-2765
St. Michael's Hospital Stevens Point, Wisconsin  54481
Urology Healthcare Associates Westampton, New Jersey  08060
Southeast Urology Network Memphis, Tennessee  38119
Urology San Antonio Research, PA San Antonio, Texas  78229
West Coast Clinical Research Tarzana, California  91356
State College Urologic Association State College, Pennsylvania  16801
Coastal Clinical Research Mobile, Alabama  36608
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
Palo Alto VA Palo Alto, California  94305
Urological Physicians of San Diego San Diego, California  92103
Veterans Medical Research Foundation San Diego, California  92161
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
Urology Consultants Inc. Clearwater, Florida  33761
Advance Research Institute New Port Richey, Florida  34652
Central Florida Urology Group/ UroSearch Ocala, Florida  34474
Panama City Urology Panama City Beach, Florida  32405
Pinellas Urology St. Petersburg, Florida  33710
Tampa Bay Urology Tampa, Florida  33607
Cleveland Clinic-Florida Weston, Florida  33331
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
Prairie Medical Associates Chicago, Illinois  60616
Special Care Research Peoria, Illinois  61614
MMPC Urology Greenwood, Indiana  49546
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
The Fallon Clinic Worcester, Massachusetts  01605
Wayne Glazier Worcester, Massachusetts  01605
Beaumont Medical Royal Oak, Michigan  48073
Mayo Clinic Urology Department Rochester, Minnesota  55905
Park Nicollet Urology St. Louis Park, Minnesota  55416
Kansas City Urology, PC Kansas, 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 Inst. Of New York Albany, New York  12208
William Oberheim Albany, New York  12208
Metropolitan Urologic Services, PC Elmont, New York  11003
University Urology Associates New York, New York  10016
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
Wake Urology Raleigh, North Carolina  27607
Summa Health Care Akron, Ohio  44304
Cleveland Clinic Lerner College of Medicine Cleveland, Ohio  44195
Colombus Urology Research Columbus, Ohio  43214
Urology of Northern Ohio Elyria, Ohio  44035
The Corvallis Clinic Corvallis, Oregon  97330
Urologic Surgery Bala Cynwyd, Pennsylvania  19004
The Urology Institute Monroeville, Pennsylvania  15146
Ginsberg and Harkaway Urology Philadelphia, Pennsylvania  19141
Radiant Research Greer, South Carolina  29651
Center for Urological Treatment Nashville, Tennessee  37203
Ace Research Specialists Nashville, Tennessee  37203
Breco Research Houston, Texas  77024
Urology Consultants, 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
Med Atlantic, Inc (Virginia Urology) Richmond, Virginia  23235
Seattle VAMC Seattle, Washington  98108
University of Wisconsin Medical School: Clinical Trials Madison, Wisconsin  53715
Froedtert Memorial Lutheran Hospital Department of Urology Milwaukee, Wisconsin  53226