Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trials Reporting System)
REGISTRY · PDQ (Physician Data Query)
interventional
71
2 countries
114
Study Start
November 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2006
Actual (reported)Study Completion
January 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 5, 2002
Actual (reported)November 2002
Date type not reportedThis date has not been verified as actual or estimated.
January 27, 2003
Actual (reported)June 2006
Actual (reported)January 2010
Actual (reported)Bone mineral density by test at 1 and 2 years
Up to 2 years
Toxicity questionnaires every 6 months
6 months
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.
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.
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, 85259, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224-9980, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, 60507, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Kearns AE, Northfelt DW, Dueck AC, Atherton PJ, Dakhil SR, Rowland KM Jr, Fuloria J, Flynn PJ, Dentchev T, Loprinzi CL. Osteoporosis prevention in prostate cancer patients receiving androgen ablation therapy: placebo-controlled double-blind study of estradiol and risedronate: N01C8. Support Care Cancer. 2010 Mar;18(3):321-8. doi: 10.1007/s00520-009-0655-x. Epub 2009 May 27.
Charles L. Loprinzi, MD
Mayo Clinic
71 participants (actual enrollment reported by the registry).
First Submitted
August 5, 2002
First Posted
January 27, 2003
Study Start
November 2002
Date type not reportedThis date has not been verified as actual or estimated.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Galesburg Clinic
Galesburg, Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hopedale Medical Complex
Hopedale, Illinois, 61747, United States
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, 60435, United States
Kewanee Hospital
Kewanee, Illinois, 61443, United States
McDonough District Hospital
Macomb, Illinois, 61455, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa, Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61615, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
St. Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Valley Cancer Center
Spring Valley, Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360, United States
McFarland Clinic, P.C.
Ames, Iowa, 50010, United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401, United States
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503, United States
Mercy Capitol Hospital
Des Moines, Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, 50401, United States
Alegent Health Community Memorial Hospital
Missouri Valley, Iowa, 51555, United States
Burgess Health Center
Onawa, Iowa, 51040, United States
Cancer Center at Ottumwa Regional Health Center
Ottumwa, Iowa, 52501, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101-1733, United States
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, 50266, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Kingman
Kingman, Kansas, 67068, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, 67357, United States
Pratt Cancer Center of Kansas
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67042, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health
Wichita, Kansas, 67203, United States
Cancer Center of Kansas, P.A.
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Brainerd Medical Center
Brainerd, Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Miller-Dwan Medical Center
Duluth, Minnesota, 55805, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
Fridley, Minnesota, 55432, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55403, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic
Saint Louis Park, Minnesota, 55416, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Sletten Regional Cancer Institute
Great Falls, Montana, 59405, United States
Fremont Area Medical Center
Fremont, Nebraska, 68025, United States
Bryan LGH Medical Center West
Lincoln, Nebraska, 68502, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510, United States
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Cancer Center at Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, 68046, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Bismarck Cancer Center
Bismarck, North Dakota, 58501, United States
Medcenter One Health System
Bismarck, North Dakota, 58501, United States
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, 58501, United States
St. Alexius Medical Center
Bismarck, North Dakota, 58501, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, 58201, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, 29621, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29304, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, 57104, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57105, United States
Medical X-Ray Center
Sioux Falls, South Dakota, 57105, United States
Pasqua Hospital
Regina, Saskatchewan, S4T 1A5, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, S4T 7T1, Canada
Primary Completion
June 2006
Actual (reported)Study Completion
January 2010
Actual (reported)Last Updated
December 7, 2016
Record last verified: 2016-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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