Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer
- Conditions
- Prostate CancerOsteoporosis
- Interventions
- Dietary Supplement: calcium carbonateDietary Supplement: cholecalciferolDrug: Estrogen AntagonistsOther: placebo
- Registration Number
- NCT00043069
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Preventing bone loss in patients who are undergoing androgen ablation for prostate cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without estrogen and/or risedronate in preventing osteoporosis.
PURPOSE: Randomized phase III trial to compare the effectiveness of two forms of calcium with or without estrogen and/or risedronate in preventing osteoporosis in patients with prostate cancer who are receiving androgen ablation therapy.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 71
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm IV: calcium + cholecalciferol + risedronate + estrogen cholecalciferol 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. Arm I: calcium + cholecalciferol + placebo + estrogen placebo Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo 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. Arm II: calcium + cholecalciferol + risedronate + estrogen cholecalciferol Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo 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. Arm II: calcium + cholecalciferol + risedronate + estrogen Estrogen Antagonists Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo 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. Arm IV: calcium + cholecalciferol + risedronate + estrogen calcium carbonate 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. Arm III: calcium + cholecalciferol + placebo + estrogen calcium carbonate Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate placebo 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. Arm I: calcium + cholecalciferol + placebo + estrogen calcium carbonate Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo 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. Arm I: calcium + cholecalciferol + placebo + estrogen cholecalciferol Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo 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. Arm I: calcium + cholecalciferol + placebo + estrogen Estrogen Antagonists Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo 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. Arm II: calcium + cholecalciferol + risedronate + estrogen calcium carbonate Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo 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. Arm III: calcium + cholecalciferol + placebo + estrogen cholecalciferol Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate placebo 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. Arm III: calcium + cholecalciferol + placebo + estrogen Estrogen Antagonists Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate placebo 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. Arm III: calcium + cholecalciferol + placebo + estrogen placebo Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate placebo 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. Arm IV: calcium + cholecalciferol + risedronate + estrogen Estrogen Antagonists 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. Arm II: calcium + cholecalciferol + risedronate + estrogen risedronate sodium Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo 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. Arm IV: calcium + cholecalciferol + risedronate + estrogen risedronate sodium 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.
- Primary Outcome Measures
Name Time Method Bone mineral density by test at 1 and 2 years Up to 2 years
- Secondary Outcome Measures
Name Time Method Toxicity questionnaires every 6 months 6 months
Trial Locations
- Locations (114)
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Eureka Hospital
🇺🇸Eureka, Illinois, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
InterCommunity Cancer Center of Western Illinois
🇺🇸Galesburg, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Joliet Oncology Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois - Ottawa
🇺🇸Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
McFarland Clinic, P.C.
🇺🇸Ames, Iowa, United States
Saint Anthony Regional Hospital
🇺🇸Carroll, Iowa, United States
Alegent Health Mercy Hospital
🇺🇸Council Bluffs, Iowa, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
Burgess Health Center
🇺🇸Onawa, Iowa, United States
Alegent Health Community Memorial Hospital
🇺🇸Missouri Valley, Iowa, United States
Siouxland Regional Cancer Center
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas - Chanute
🇺🇸Chanute, Kansas, United States
Siouxland Hematology-Oncology Associates
🇺🇸Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas - Salina
🇺🇸Salina, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CentraCare Clinic - River Campus
🇺🇸St. Cloud, Minnesota, United States
Park Nicollet Clinic
🇺🇸St. Louis Park, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Sletten Regional Cancer Institute
🇺🇸Great Falls, Montana, United States
Bryan LGH Medical Center West
🇺🇸Lincoln, Nebraska, United States
St. Elizabeth Regional Medical Center
🇺🇸Lincoln, Nebraska, United States
Midlands Cancer Center at Midlands Community Hospital
🇺🇸Papillion, Nebraska, United States
Medcenter One Health System
🇺🇸Bismarck, North Dakota, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Cancer Center of Kansas, P.A. - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons
🇺🇸Parsons, Kansas, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Mid Dakota Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
Miller-Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
St. Mary's - Duluth Clinic Cancer Center
🇺🇸Duluth, Minnesota, United States
Associates in Womens Health
🇺🇸Wichita, Kansas, United States
Pratt Cancer Center of Kansas
🇺🇸Pratt, Kansas, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Cancer Center of Kansas - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas - Wellington
🇺🇸Wellington, Kansas, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Cancer Center of Kansas - Winfield
🇺🇸Winfield, Kansas, United States
Brainerd Medical Center
🇺🇸Brainerd, Minnesota, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
Cancer Center of Kansas, P.A.
🇺🇸Wichita, Kansas, United States
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
🇺🇸Fridley, Minnesota, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
United Hospital
🇺🇸St. Paul, Minnesota, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Fremont Area Medical Center
🇺🇸Fremont, Nebraska, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Allan Blair Cancer Centre at Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
🇺🇸Anderson, South Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Avera McKennan Hospital and University Health Center
🇺🇸Sioux Falls, South Dakota, United States
Medical X-Ray Center
🇺🇸Sioux Falls, South Dakota, United States
Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Cancer Center at Ottumwa Regional Health Center
🇺🇸Ottumwa, Iowa, United States
Geisinger Medical Group
🇺🇸State College, Pennsylvania, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Cancer Center at Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States