Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer

NCT00043069 | Completed Phase 3 DMC

• 4 other identifiers: NCCTG-N01C8NCI-2012-02482NCI-P02-0229CDR0000069502
• Study Type: interventional
• Target: 71
• Locations: 2 countries
• Sites: 114

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.

Conditions

Osteoporosis; Prostate Cancer

Keywords

osteoporosis; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• Bone mineral density by test at 1 and 2 years

  Up to 2 years

Secondary Outcomes (1)

• Toxicity questionnaires every 6 months

  6 months

Study Arms (4)

Arm I: calcium + cholecalciferol + placebo + estrogen

ACTIVE COMPARATOR

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.

Dietary Supplement: calcium carbonate; Dietary Supplement: cholecalciferol; Drug: Estrogen Antagonists; Other: placebo

Arm II: calcium + cholecalciferol + risedronate + estrogen

EXPERIMENTAL

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.

Dietary Supplement: calcium carbonate; Dietary Supplement: cholecalciferol; Drug: Estrogen Antagonists; Drug: risedronate sodium

Arm III: calcium + cholecalciferol + placebo + estrogen

PLACEBO COMPARATOR

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.

Dietary Supplement: calcium carbonate; Dietary Supplement: cholecalciferol; Drug: Estrogen Antagonists; Other: placebo

Arm IV: calcium + cholecalciferol + risedronate + estrogen

EXPERIMENTAL

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.

Dietary Supplement: calcium carbonate; Dietary Supplement: cholecalciferol; Drug: Estrogen Antagonists; Drug: risedronate sodium

Interventions

calcium carbonate DIETARY_SUPPLEMENT

Arm I: calcium + cholecalciferol + placebo + estrogen; Arm II: calcium + cholecalciferol + risedronate + estrogen; Arm III: calcium + cholecalciferol + placebo + estrogen; Arm IV: calcium + cholecalciferol + risedronate + estrogen

cholecalciferol DIETARY_SUPPLEMENT

Arm I: calcium + cholecalciferol + placebo + estrogen; Arm II: calcium + cholecalciferol + risedronate + estrogen; Arm III: calcium + cholecalciferol + placebo + estrogen; Arm IV: calcium + cholecalciferol + risedronate + estrogen

Estrogen Antagonists DRUG

Arm I: calcium + cholecalciferol + placebo + estrogen; Arm II: calcium + cholecalciferol + risedronate + estrogen; Arm III: calcium + cholecalciferol + placebo + estrogen; Arm IV: calcium + cholecalciferol + risedronate + estrogen

risedronate sodium DRUG

Arm II: calcium + cholecalciferol + risedronate + estrogen; Arm IV: calcium + cholecalciferol + risedronate + estrogen

placebo OTHER

Arm I: calcium + cholecalciferol + placebo + estrogen; Arm III: calcium + cholecalciferol + placebo + estrogen

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * History of prostate cancer * No evidence of metastatic bony disease\* NOTE: \*Elevated prostate-specific antigen (PSA) allowed * Meets one of the following criteria: * Currently on treatment with androgen-ablation therapy in the adjuvant setting * Rising PSA without other evidence of recurrent disease with planned treatment for at least 6 months * No known osteoporosis or prior osteoporotic fracture * Osteoporosis defined as bone density at the hip or spine of more than 2.5 standard deviations below the mean for young men PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * SGOT or SGPT no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase normal OR no greater than 1.5 times ULN with a normal bone scan Renal * Creatinine no greater than 1.5 times ULN * No prior symptomatic hypercalcemia or hypocalcemia Cardiovascular * No active heart disease * No congestive heart failure under active treatment * No myocardial infarction within the past 5 years * No coronary artery disease (CAD) with recent myocardial infarction * Patients with a remote history of CAD who are only on medical treatment (e.g., antilipid agents) are allowed * No prior thrombosis (deep vein thrombosis, stroke, or pulmonary embolism) or other known hypercoagulable state other than cancer Other * Fertile patients must use effective contraception * Triglycerides no greater than 250 mg/dL (treatment allowed) * Able to complete questionnaire(s) by self or with assistance * Able to swallow pills * No prior hyperlipidemia (e.g., prior familial hyperlipidemia or fasting triglyceride greater than 250 mg/dL within the past 6 months) * No sarcoidosis * No parathyroid dysfunction * No intolerance to bisphosphonates PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No concurrent chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent systemic steroids Radiotherapy * No concurrent radiotherapy Surgery * More than 3 months since prior and no concurrent dental extraction, root canal, or dental implantation Other * No prior bisphosphonates * More than 5 years since prior percutaneous transluminal coronary angioplasty

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (114)

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224-9980, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Eureka Hospital

Eureka, Illinois, 61530, United States

Location

Galesburg Clinic

Galesburg, Illinois, 61401, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

InterCommunity Cancer Center of Western Illinois

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex

Hopedale, Illinois, 61747, United States

Location

Joliet Oncology Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

McDonough District Hospital

Macomb, Illinois, 61455, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Oncology Hematology Associates of Central Illinois - Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61603, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61615, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

St. Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Valley Cancer Center

Spring Valley, Illinois, 61362, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

McFarland Clinic, P.C.

Ames, Iowa, 50010, United States

Location

Saint Anthony Regional Hospital

Carroll, Iowa, 51401, United States

Location

Alegent Health Mercy Hospital

Council Bluffs, Iowa, 51503, United States

Location

Mercy Capitol Hospital

Des Moines, Iowa, 50307, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, 50314, United States

Location

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States

Location

Mercy Cancer Center at Mercy Medical Center - North Iowa

Mason City, Iowa, 50401, United States

Location

Alegent Health Community Memorial Hospital

Missouri Valley, Iowa, 51555, United States

Location

Burgess Health Center

Onawa, Iowa, 51040, United States

Location

Cancer Center at Ottumwa Regional Health Center

Ottumwa, Iowa, 52501, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101-1733, United States

Location

Siouxland Hematology-Oncology Associates

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Medical Oncology and Hematology Associates - West Des Moines

West Des Moines, Iowa, 50266, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, P.A. - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, P.A. - Parsons

Parsons, Kansas, 67357, United States

Location

Pratt Cancer Center of Kansas

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67042, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, P.A.

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, P.A. - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

Brainerd Medical Center

Brainerd, Minnesota, 56401, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Miller-Dwan Medical Center

Duluth, Minnesota, 55805, United States

Location

St. Mary's - Duluth Clinic Cancer Center

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Mercy and Unity Hospitals

Fridley, Minnesota, 55432, United States

Location

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55403, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

Robbinsdale, Minnesota, 55422, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Clinic

Saint Louis Park, Minnesota, 55416, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Sletten Regional Cancer Institute

Great Falls, Montana, 59405, United States

Location

Fremont Area Medical Center

Fremont, Nebraska, 68025, United States

Location

Bryan LGH Medical Center West

Lincoln, Nebraska, 68502, United States

Location

Cancer Resource Center - Lincoln

Lincoln, Nebraska, 68510, United States

Location

St. Elizabeth Regional Medical Center

Lincoln, Nebraska, 68510, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Immanuel Medical Center

Omaha, Nebraska, 68122, United States

Location

Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Cancer Center at Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Midlands Cancer Center at Midlands Community Hospital

Papillion, Nebraska, 68046, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Bismarck Cancer Center

Bismarck, North Dakota, 58501, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

Mid Dakota Clinic, P.C.

Bismarck, North Dakota, 58501, United States

Location

St. Alexius Medical Center

Bismarck, North Dakota, 58501, United States

Location

Altru Cancer Center at Altru Hospital

Grand Forks, North Dakota, 58201, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Geisinger Medical Group

State College, Pennsylvania, 16801, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Rose Ramer Cancer Clinic at Anderson Area Medical Center

Anderson, South Carolina, 29621, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29304, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57104, United States

Location

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center

Sioux Falls, South Dakota, 57105, United States

Location

Pasqua Hospital

Regina, Saskatchewan, S4T 1A5, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

• 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.

  PMID: 19468757 RESULT

MeSH Terms

Conditions

Osteoporosis; Prostatic Neoplasms

Interventions

Calcium Carbonate; Cholecalciferol; Estrogen Antagonists; Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Charles L. Loprinzi, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2002
• First Posted: January 27, 2003
• Study Start: November 1, 2002
• Primary Completion: June 1, 2006
• Study Completion: January 1, 2010
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

CA (2); US (112)