Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy: A Phase III Randomized, Placebo-Controlled, Double-Blind Study
OBJECTIVES:
- Compare the change in bone mineral density in patients with prostate cancer who are
receiving androgen-ablation therapy treated with calcium and cholecalciferol with or
without conjugated estrogens and with or without risedronate.
- Compare the toxicity of these regimens in these patients.
- Compare the changes in bone markers in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare hot flashes in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to duration of therapy with luteinizing hormone-releasing hormone
agonists (no more than 30 days vs 31 to 150 days vs 151 to 365 days vs more than 365 days).
Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo,
and oral estrogen placebo daily.
- Arm II: Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral
estrogen placebo daily.
- Arm III: Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated
estrogens, and oral risedronate placebo daily.
- Arm IV: Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated
estrogens, and oral risedronate daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
PROJECTED ACCRUAL: A total of 282 patients (70 per treatment arm) will be accrued for this
study within 14 months.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Bone mineral density by test at 1 and 2 years
Charles L. Loprinzi, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000069502
NCT00043069
November 2002
Name | Location |
---|---|
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Midlands Cancer Center at Midlands Community Hospital | Papillion, Nebraska 68128-4157 |
Great Falls Clinic | Great Falls, Montana 59405 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
Siouxland Hematology-Oncology Associates | Sioux City, Iowa 51101 |
Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas, P.A. - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Kingman | Kingman, Kansas 67068 |
Southwest Medical Center | Liberal, Kansas 67901 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, P.A. - Parsons | Parsons, Kansas 67357 |
Pratt Cancer Center of Kansas | Pratt, Kansas 67124 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, P.A. | Wichita, Kansas 67208 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas, P.A. - Wichita | Wichita, Kansas 67214 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Sletten Regional Cancer Institute | Great Falls, Montana 59405 |
Avera McKennan Hospital and University Health Center | Sioux Falls, South Dakota 57105 |
Medical X-Ray Center | Sioux Falls, South Dakota 57105 |
Medcenter One Health System | Bismarck, North Dakota 58501 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Burgess Health Center | Onawa, Iowa 51040 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Brainerd Medical Center | Brainerd, Minnesota 56401 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Bryan LGH Medical Center West | Lincoln, Nebraska 68502 |
St. Elizabeth Regional Medical Center | Lincoln, Nebraska 68510 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center | Bismarck, North Dakota 58502 |
Eureka Hospital | Eureka, Illinois 61530 |
Joliet Oncology Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Oncology Hematology Associates of Central Illinois - Ottawa | Ottawa, Illinois 61350 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Mercy and Unity Cancer Center at Mercy and Unity Hospitals | Fridley, Minnesota 55432-2799 |
Park Nicollet Clinic | St. Louis Park, Minnesota 55416 |
Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina 29621 |
McFarland Clinic, P.C. | Ames, Iowa 50010 |
Saint Anthony Regional Hospital | Carroll, Iowa 51401 |
Miller-Dwan Medical Center | Duluth, Minnesota 55805 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Fremont Area Medical Center | Fremont, Nebraska 68025-2387 |
Mid Dakota Clinic, P.C. | Bismarck, North Dakota 58501 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |
Alegent Health Mercy Hospital | Council Bluffs, Iowa 51503 |
Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Alegent Health Community Memorial Hospital | Missouri Valley, Iowa 51555 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Cancer Center at Creighton University Medical Center | Omaha, Nebraska 68131 |
Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Cancer Center at Ottumwa Regional Health Center | Ottumwa, Iowa 52501 |