Back to resultsToremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy
Primary Purpose
Prostate Cancer, Osteoporosis, Fractures
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Toremifene Citrate
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring Prostate cancer, Bone Loss, Osteoporosis, Fractures, Androgen Deprivation Therapy
Eligibility Criteria
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
Sites / Locations
- Urology Centers of Alabama
- Coastal Clinical Research
- Arkansas Urology
- Advanced Urology Medical Center Clinical Trials
- Urological Sciences Research Foudation
- Urological Associates of Central CA
- Center of Urologic Research
- South Orange County Medical Research Center
- Palo Alto VA
- San Bernadino Urological Associates
- Urological Physicians of San Diego
- Veterans Medical Research Foundation
- Pacific Clinical Research
- West Coast Clinical Research
- Western Clinical Research, Inc.
- Urology Associates
- Western Urological Research
- Urologic Center
- Urological Associates of Bridgeport
- Connecticut Clinical Research
- Walter Reed Army Medical Center
- South Florida Medical Research
- Urology Consultants Inc.
- Atlantic Urological Associates
- Urosearch
- Lakeland Regional Medical Center
- Advance Research Institute
- Central Florida Urology Group/ UroSearch
- Florida Foundation for Healthcare Research
- Winter Park Urology Associates
- Panama City Urology
- Pinellas Urology
- Southeastern Research Group
- Tampa Bay Urology
- UroSearch
- Cleveland Clinic-Florida
- Midtown Urology
- Georgia Urology
- St. Joseph Research Institute
- Augusta VAMC
- Southeastern Medical Research Institute
- Urology Enterprises
- Harbin Clinic Department of Urology Research
- North Fulton Urology
- St. Joseph's, Candler Health System
- North Idaho Urology
- Prairie Medical Associates
- Medical and Surgical Specialists
- Special Care Research
- Urology of Indiana, LLC
- MMPC Urology
- Metropolitan Urology
- Heartland Research Associates, LLC
- LSUHSC/Stanley Scott Cancer Center
- Regional Urology LLC
- Anne Arundel Urology P.A.
- Maryland Prostate Center: University of Maryland Medical Center
- Urology Center, PA
- Mid Atlantic Clinical Research
- The Fallon Clinic
- Wayne Glazier
- University of Michigan Comprehensive Cancer Center
- Beaumont Medical
- Mayo Clinic Urology Department
- Park Nicollet Urology
- Kansas City Urology, PC
- PPS Clinical Research
- Urologic Research Center
- Sheldon Freeman
- Urologic Surgeons, Ltd.
- Coastal Urology Associates
- Hamilton Urology PA
- Lawrenceville Urology Associates
- Assoc. Urologic Specialists
- Urology Healthcare Associates
- Urology Group of New Mexico
- Urology Inst. Of New York
- William Oberheim
- Metropolitan Urologic Services, PC
- Urological Surgeons of Long Island
- University Urology Associates
- Mount Sinai School of Medicine
- CNY Urology
- Staten Island Urological Research , PC
- Associated Urologists of CNY
- Center for Urologic Research WNY, LLC
- Asheboro Urology
- University of North Carolina
- The Urology Center
- Wake Urology
- Piedmont Medical Research Associates
- Odyssey Research
- Summa Health Care
- The Urology Group
- Cleveland Clinic Lerner College of Medicine
- Colombus Urology Research
- Urology of Northern Ohio
- Southwest Urology
- Oklahoma University Medical Center
- Urologic Specialists of Oklahoma, Inc.
- The Corvallis Clinic
- Oregon Urology Specialists
- Urologic Associates of Allentown
- Urologic Surgery
- Urological Associates of Lancaster, Ltd.
- The Urology Institute
- University of Pennsylvania
- Ginsberg and Harkaway Urology
- University of Pittsburgh
- State College Urologic Association
- University Urological Research Institute
- Radiant Research
- Carolina Urologic Research Center
- Volunteer Research Group
- Southeast Urology Network
- Ace Research Specialists
- Center for Urological Treatment
- Urology Associates
- Vanderbilt Medical Center
- Professional Quality Research
- Breco Research
- Urology Consultants, PA
- Urology San Antonio Research, PA
- Scott and White Clinical Hospital
- Salt Lake City Research
- Adult and Pediatric Urologists of Northern VA
- Devine Tidewater Urology
- Med Atlantic, Inc (Virginia Urology)
- McGuire VA Medical Center
- Seattle VAMC
- Deaconess Medical Center
- Madigan Army Medical Center
- University of Wisconsin Medical School: Clinical Trials
- St. Michael's Hospital
- Froedtert Memorial Lutheran Hospital Department of Urology
- Wyoming Research Foundation
- American British Cowdray Hospital
- Centro Medico Dalinde
- Hospital General de Mexico
- Hospital Regional "Gabriel Mancera", IMSS
- Centro Medico Naval
- Hospital General de Zona No. 1-A
- Clinica Londres
- Hospital Central Militar, SDN
- Hospital Medica Sur
- Hospital de Oncologia CMN Siglo XXI, IMSS
- Hospital General de Zona No. 26, Mexico D.F.
- Hospital General Region 1 de Octubre, ISSSTE
- Hospital Civil Viejo "Fray Antonio Alcalde"
- Centro Medico de Occidente-IMSS
- Hospital Regional Dr Valentin Gomez Farias, ISSSTE
- Hospital Regional de Especialidades
- Hospital Universitario
- Hospital Ignacio Morones Prieto
- Hospital General de Zona con UMF No. 2 San Luis Potosi
Outcomes
Primary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00129142
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 Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GTx
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Osteoporosis, Fractures
Keywords
Prostate cancer, Bone Loss, Osteoporosis, Fractures, Androgen Deprivation Therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
1200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Toremifene Citrate
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Percentage of subjects with at least one new or worsening vertebral fracture at 24 months
Title
Percentage of subjects with a clinical fragility fracture at 12 and 24 months
Title
Percent change from baseline in lumbar bone mineral density (BMD) as measured by dual energy x-ray absorptiometry (DEXA) scan at 24 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Steiner, M.D.
Organizational Affiliation
GTx
Official's Role
Study Director
Facility Information:
Facility Name
Urology Centers of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Coastal Clinical Research
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Arkansas Urology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Advanced Urology Medical Center Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Urological Sciences Research Foudation
City
Culver City
State/Province
California
ZIP/Postal Code
90232
Country
United States
Facility Name
Urological Associates of Central CA
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Center of Urologic Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
South Orange County Medical Research Center
City
Laguna Woods
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Palo Alto VA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
San Bernadino Urological Associates
City
San Bernadino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
Urological Physicians of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Veterans Medical Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Pacific Clinical Research
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
West Coast Clinical Research
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Western Clinical Research, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Urology Associates
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Western Urological Research
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Urologic Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Urological Associates of Bridgeport
City
Trumball
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Connecticut Clinical Research
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Urology Consultants Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Atlantic Urological Associates
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Urosearch
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Lakeland Regional Medical Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Advance Research Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Central Florida Urology Group/ UroSearch
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Florida Foundation for Healthcare Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Winter Park Urology Associates
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Panama City Urology
City
Panama City Beach
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Pinellas Urology
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Southeastern Research Group
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Tampa Bay Urology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
UroSearch
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
Cleveland Clinic-Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Midtown Urology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Georgia Urology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
St. Joseph Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Augusta VAMC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Southeastern Medical Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Urology Enterprises
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Harbin Clinic Department of Urology Research
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
North Fulton Urology
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
St. Joseph's, Candler Health System
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
North Idaho Urology
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Prairie Medical Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Medical and Surgical Specialists
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Special Care Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Urology of Indiana, LLC
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
MMPC Urology
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
49546
Country
United States
Facility Name
Metropolitan Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
LSUHSC/Stanley Scott Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Regional Urology LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Anne Arundel Urology P.A.
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Maryland Prostate Center: University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Urology Center, PA
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Mid Atlantic Clinical Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
28050
Country
United States
Facility Name
The Fallon Clinic
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Wayne Glazier
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Beaumont Medical
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Mayo Clinic Urology Department
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Park Nicollet Urology
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Kansas City Urology, PC
City
Kansas
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
PPS Clinical Research
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Urologic Research Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Sheldon Freeman
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Urologic Surgeons, Ltd.
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Coastal Urology Associates
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Hamilton Urology PA
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Lawrenceville Urology Associates
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Assoc. Urologic Specialists
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Urology Healthcare Associates
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Urology Group of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Urology Inst. Of New York
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
William Oberheim
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Metropolitan Urologic Services, PC
City
Elmont
State/Province
New York
ZIP/Postal Code
11003
Country
United States
Facility Name
Urological Surgeons of Long Island
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
University Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
CNY Urology
City
Oneida
State/Province
New York
ZIP/Postal Code
13421
Country
United States
Facility Name
Staten Island Urological Research , PC
City
Staten Island
State/Province
New York
ZIP/Postal Code
10304
Country
United States
Facility Name
Associated Urologists of CNY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Center for Urologic Research WNY, LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Asheboro Urology
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27559
Country
United States
Facility Name
The Urology Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Wake Urology
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Piedmont Medical Research Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Odyssey Research
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Summa Health Care
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Cleveland Clinic Lerner College of Medicine
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Colombus Urology Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Urology of Northern Ohio
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Southwest Urology
City
Parma
State/Province
Ohio
ZIP/Postal Code
44129
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Urologic Specialists of Oklahoma, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
12208
Country
United States
Facility Name
The Corvallis Clinic
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Oregon Urology Specialists
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Urologic Associates of Allentown
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Urologic Surgery
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Urological Associates of Lancaster, Ltd.
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
The Urology Institute
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Ginsberg and Harkaway Urology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
State College Urologic Association
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
University Urological Research Institute
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Radiant Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Southeast Urology Network
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Ace Research Specialists
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Center for Urological Treatment
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Urology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Professional Quality Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Breco Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Urology Consultants, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Urology San Antonio Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Scott and White Clinical Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Salt Lake City Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Adult and Pediatric Urologists of Northern VA
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Devine Tidewater Urology
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Med Atlantic, Inc (Virginia Urology)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Seattle VAMC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Deaconess Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
University of Wisconsin Medical School: Clinical Trials
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
St. Michael's Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Froedtert Memorial Lutheran Hospital Department of Urology
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Wyoming Research Foundation
City
Cheyenne
State/Province
Wyoming
ZIP/Postal Code
82001
Country
United States
Facility Name
American British Cowdray Hospital
City
Mexico City
State/Province
D. F
ZIP/Postal Code
01120
Country
Mexico
Facility Name
Centro Medico Dalinde
City
Mexico City
State/Province
D. F
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Hospital General de Mexico
City
Mexico City
State/Province
D. F
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Hospital Regional "Gabriel Mancera", IMSS
City
Mexico City
State/Province
D.f,
Country
Mexico
Facility Name
Centro Medico Naval
City
Mexico City
State/Province
D.f.
ZIP/Postal Code
01090
Country
Mexico
Facility Name
Hospital General de Zona No. 1-A
City
Mexico City
State/Province
D.f.
ZIP/Postal Code
03300
Country
Mexico
Facility Name
Clinica Londres
City
Mexico City
State/Province
D.f.
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Hospital Central Militar, SDN
City
Mexico City
State/Province
D.f.
ZIP/Postal Code
11649
Country
Mexico
Facility Name
Hospital Medica Sur
City
Mexico City
State/Province
D.f.
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Hospital de Oncologia CMN Siglo XXI, IMSS
City
Mexico City
State/Province
D.f.
Country
Mexico
Facility Name
Hospital General de Zona No. 26, Mexico D.F.
City
Mexico City
State/Province
D.f.
Country
Mexico
Facility Name
Hospital General Region 1 de Octubre, ISSSTE
City
Mexico City
State/Province
D.F
ZIP/Postal Code
07300
Country
Mexico
Facility Name
Hospital Civil Viejo "Fray Antonio Alcalde"
City
Guadalajara
State/Province
Jal
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Centro Medico de Occidente-IMSS
City
Guadalajara
State/Province
Jal
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Hospital Regional Dr Valentin Gomez Farias, ISSSTE
City
Guadalajara
State/Province
Jal
Country
Mexico
Facility Name
Hospital Regional de Especialidades
City
Monterrey
State/Province
N.l.
ZIP/Postal Code
64320
Country
Mexico
Facility Name
Hospital Universitario
City
Monterrey
State/Province
N.l.
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital Ignacio Morones Prieto
City
San Luis Potosi
State/Province
S.l.p.
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Hospital General de Zona con UMF No. 2 San Luis Potosi
City
San Luis Potosi
State/Province
S.l.p.
ZIP/Postal Code
78270
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
23234631
Citation
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.
Results Reference
derived
PubMed Identifier
22245322
Citation
Morgans 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.
Results Reference
derived
Learn more about this trial
Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy
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