Know Cancer

forgot password

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 CenterAnn Arbor, Michigan  48109-0752
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Mount Sinai School of MedicineNew York, New York  10029
Deaconess Medical CenterSpokane, Washington  99210-0248
Madigan Army Medical CenterTacoma, Washington  98431-5048
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Mid Atlantic Clinical ResearchRockville, Maryland  20850
Atlantic Urological AssociatesDaytona Beach, Florida  32114
Georgia UrologyAtlanta, Georgia  30342
San Bernadino Urological AssociatesSan Bernadino, California  92404
Lakeland Regional Medical CenterLakeland, Florida  33804
University of PittsburghPittsburgh, Pennsylvania  15261
Devine Tidewater UrologyNorfolk, Virginia  23507
University of North CarolinaChapel Hill, North Carolina  27599
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
South Florida Medical ResearchAventura, Florida  33180
UroSearchLeesburg, Florida  34748
North Idaho UrologyCouer D'Alene, Idaho  83814
Pacific Clinical ResearchSanta Monica, California  90404
Urology of Indiana, LLCIndianapolis, Indiana  46202
Florida Foundation for Healthcare ResearchOcala, Florida  34474
Winter Park Urology AssociatesOrlando, Florida  32803
The Urology GroupCincinnati, Ohio  45212
Southwest UrologyParma, Ohio  44129
Urology Centers Of AlabamaHomewood,, Alabama  35205
Western Clinical Research, Inc.Torrance,, California  90505-4763
The Urology CenterGreensboro,, North Carolina  27401
Urologic Specialists Of Oklahoma, Inc.Tulsa,, Oklahoma  74104-5433
Oregon Urology SpecialistsEugene, Oregon  97401
Urologic Associates of AllentownAllentown, Pennsylvania  18103
Urology AssociatesNashville, Tennessee  37209
Wyoming Research FoundationCheyenne, Wyoming  82001
South Orange County Medical Research CenterLaguna Hills, California  92653
Professional Quality ResearchAustin, Texas  78756
Urological Associates of Lancaster, Ltd.Lancaster, Pennsylvania  17604
University Urological Research InstituteProvidence, Rhode Island  02904
Heartland Research Associates, LLCWichita, Kansas  67207
Arkansas UrologyLittle Rock, Arkansas  72211
Urological Surgeons of Long IslandGarden City, New York  11530
McGuire VA Medical CenterRichmond, Virginia  23249
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Midtown UrologyAtlanta, Georgia  30308
Medical and Surgical SpecialistsGalesburg, Illinois  61401
Metropolitan UrologyJeffersonville, Indiana  47130
Urology Group of New MexicoAlbuquerque, New Mexico  87109
Odyssey ResearchBismarck, North Dakota  58501
Volunteer Research GroupKnoxville, Tennessee  37920
Southeastern Research GroupTallahassee, Florida  32308
Piedmont Medical Research AssociatesWinston Salem, North Carolina  27103
Vanderbilt Medical CenterNashville, Tennessee  37232-2765
St. Michael's HospitalStevens Point, Wisconsin  54481
Urology Healthcare AssociatesWestampton, New Jersey  08060
Southeast Urology NetworkMemphis, Tennessee  38119
Urology San Antonio Research, PASan Antonio, Texas  78229
West Coast Clinical ResearchTarzana, California  91356
State College Urologic AssociationState College, Pennsylvania  16801
Coastal Clinical ResearchMobile, Alabama  36608
Advanced Urology Medical Center Clinical TrialsAnaheim, California  92801
Urological Sciences Research FoudationCulver City, California  90232
Urological Associates of Central CAFresno, California  93720
Center of Urologic ResearchLa Mesa, California  91942
Palo Alto VAPalo Alto, California  94305
Urological Physicians of San DiegoSan Diego, California  92103
Veterans Medical Research FoundationSan Diego, California  92161
Urology AssociatesDenver, Colorado  80210
Western Urological ResearchWheat Ridge, Colorado  80033
Urologic CenterNew Haven, Connecticut  06511
Urological Associates of BridgeportTrumball, Connecticut  06611
Connecticut Clinical ResearchWaterbury, Connecticut  06708
Urology Consultants Inc.Clearwater, Florida  33761
Advance Research InstituteNew Port Richey, Florida  34652
Central Florida Urology Group/ UroSearchOcala, Florida  34474
Panama City UrologyPanama City Beach, Florida  32405
Pinellas UrologySt. Petersburg, Florida  33710
Tampa Bay UrologyTampa, Florida  33607
Cleveland Clinic-FloridaWeston, Florida  33331
St. Joseph Research InstituteAtlanta, Georgia  30342
Augusta VAMCAugusta, Georgia  30912
Southeastern Medical Research InstituteColumbus, Georgia  31904
Urology EnterprisesMarietta, Georgia  30060
Harbin Clinic Department of Urology ResearchRome, Georgia  30165
North Fulton UrologyRoswell, Georgia  30076
St. Joseph's, Candler Health SystemSavannah, Georgia  31405
Prairie Medical AssociatesChicago, Illinois  60616
Special Care ResearchPeoria, Illinois  61614
MMPC UrologyGreenwood, Indiana  49546
LSUHSC/Stanley Scott Cancer CenterNew Orleans, Louisiana  70112
Regional Urology LLCShreveport, Louisiana  71106
Anne Arundel Urology P.A.Annapolis, Maryland  21401
Maryland Prostate Center: University of Maryland Medical CenterBaltimore, Maryland  21201
Urology Center, PAHagerstown, Maryland  21742
The Fallon ClinicWorcester, Massachusetts  01605
Wayne GlazierWorcester, Massachusetts  01605
Beaumont MedicalRoyal Oak, Michigan  48073
Mayo Clinic Urology DepartmentRochester, Minnesota  55905
Park Nicollet UrologySt. Louis Park, Minnesota  55416
Kansas City Urology, PCKansas, Missouri  64131
PPS Clinical ResearchSt Louis, Missouri  63141
Urologic Research CenterSt. Louis, Missouri  63141
Sheldon FreemanLas Vegas, Nevada  89109
Urologic Surgeons, Ltd.Reno, Nevada  89502
Coastal Urology AssociatesBrick, New Jersey  08724
Hamilton Urology PAHamilton, New Jersey  08690
Lawrenceville Urology AssociatesLawrenceville, New Jersey  08648
Assoc. Urologic SpecialistsMarlton, New Jersey  08053
Urology Inst. Of New YorkAlbany, New York  12208
William OberheimAlbany, New York  12208
Metropolitan Urologic Services, PCElmont, New York  11003
University Urology AssociatesNew York, New York  10016
CNY UrologyOneida, New York  13421
Staten Island Urological Research , PCStaten Island, New York  10304
Associated Urologists of CNYSyracuse, New York  13210
Center for Urologic Research WNY, LLCWilliamsville, New York  14221
Asheboro UrologyAsheboro, North Carolina  27203
Wake UrologyRaleigh, North Carolina  27607
Summa Health CareAkron, Ohio  44304
Cleveland Clinic Lerner College of MedicineCleveland, Ohio  44195
Colombus Urology ResearchColumbus, Ohio  43214
Urology of Northern OhioElyria, Ohio  44035
The Corvallis ClinicCorvallis, Oregon  97330
Urologic SurgeryBala Cynwyd, Pennsylvania  19004
The Urology InstituteMonroeville, Pennsylvania  15146
Ginsberg and Harkaway UrologyPhiladelphia, Pennsylvania  19141
Radiant ResearchGreer, South Carolina  29651
Center for Urological TreatmentNashville, Tennessee  37203
Ace Research SpecialistsNashville, Tennessee  37203
Breco ResearchHouston, Texas  77024
Urology Consultants, PASan Antonio, Texas  78229
Scott and White Clinical HospitalTemple, Texas  76508
Salt Lake City ResearchSalt Lake City, Utah  84124
Adult and Pediatric Urologists of Northern VAAlexandria, Virginia  22304
Med Atlantic, Inc (Virginia Urology)Richmond, Virginia  23235
Seattle VAMCSeattle, Washington  98108
University of Wisconsin Medical School: Clinical TrialsMadison, Wisconsin  53715
Froedtert Memorial Lutheran Hospital Department of UrologyMilwaukee, Wisconsin  53226