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

Last updated: December 5, 2016
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Completed

Phase

3

Condition

Osteoporosis

Prostate Disorders

Prostate Cancer

Treatment

N/A

Clinical Study ID

NCT00043069
NCCTG-N01C8
CDR0000069502
NCI-P02-0229
NCI-2012-02482
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 71
Study Start date:
November 01, 2002
Estimated Completion Date:
January 31, 2010

Study 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.

Connect with a study center

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan S4T 7T1
    Canada

    Site Not Available

  • Pasqua Hospital

    Regina, Saskatchewan S4T 1A5
    Canada

    Site Not Available

  • CCOP - Mayo Clinic Scottsdale Oncology Program

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida 32224-9980
    United States

    Site Not Available

  • Rush-Copley Cancer Care Center

    Aurora, Illinois 60507
    United States

    Site Not Available

  • St. Joseph Medical Center

    Bloomington, Illinois 61701
    United States

    Site Not Available

  • Graham Hospital

    Canton, Illinois 61520
    United States

    Site Not Available

  • Memorial Hospital

    Carthage, Illinois 62321
    United States

    Site Not Available

  • Eureka Hospital

    Eureka, Illinois 61530
    United States

    Site Not Available

  • Galesburg Clinic

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Galesburg Cottage Hospital

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Mason District Hospital

    Havana, Illinois 62644
    United States

    Site Not Available

  • Hopedale Medical Complex

    Hopedale, Illinois 61747
    United States

    Site Not Available

  • Joliet Oncology Hematology Associates, Limited - West

    Joliet, Illinois 60435
    United States

    Site Not Available

  • Kewanee Hospital

    Kewanee, Illinois 61443
    United States

    Site Not Available

  • McDonough District Hospital

    Macomb, Illinois 61455
    United States

    Site Not Available

  • BroMenn Regional Medical Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Community Cancer Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Community Hospital of Ottawa

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Oncology Hematology Associates of Central Illinois - Ottawa

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois 61554
    United States

    Site Not Available

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Methodist Medical Center of Illinois

    Peoria, Illinois 61603
    United States

    Site Not Available

  • OSF St. Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

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

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Proctor Hospital

    Peoria, Illinois 61614
    United States

    Site Not Available

  • Illinois Valley Community Hospital

    Peru, Illinois 61354
    United States

    Site Not Available

  • Perry Memorial Hospital

    Princeton, Illinois 61356
    United States

    Site Not Available

  • St. Margaret's Hospital

    Spring Valley, Illinois 61362
    United States

    Site Not Available

  • Valley Cancer Center

    Spring Valley, Illinois 61362
    United States

    Site Not Available

  • CCOP - Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana 46360
    United States

    Site Not Available

  • McFarland Clinic, P.C.

    Ames, Iowa 50010
    United States

    Site Not Available

  • Saint Anthony Regional Hospital

    Carroll, Iowa 51401
    United States

    Site Not Available

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa 51503
    United States

    Site Not Available

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa 50316
    United States

    Site Not Available

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Mercy Capitol Hospital

    Des Moines, Iowa 50307
    United States

    Site Not Available

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa 50401
    United States

    Site Not Available

  • Alegent Health Community Memorial Hospital

    Missouri Valley, Iowa 51555
    United States

    Site Not Available

  • Burgess Health Center

    Onawa, Iowa 51040
    United States

    Site Not Available

  • Cancer Center at Ottumwa Regional Health Center

    Ottumwa, Iowa 52501
    United States

    Site Not Available

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • Siouxland Hematology-Oncology Associates

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • Siouxland Regional Cancer Center

    Sioux City, Iowa 51101-1733
    United States

    Site Not Available

  • St. Luke's Regional Medical Center

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • Medical Oncology and Hematology Associates - West Des Moines

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas 66720
    United States

    Site Not Available

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas 67801
    United States

    Site Not Available

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

    El Dorado, Kansas 67042
    United States

    Site Not Available

  • Cancer Center of Kansas - Kingman

    Kingman, Kansas 67068
    United States

    Site Not Available

  • Southwest Medical Center

    Liberal, Kansas 67901
    United States

    Site Not Available

  • Cancer Center of Kansas - Newton

    Newton, Kansas 67114
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A. - Parsons

    Parsons, Kansas 67357
    United States

    Site Not Available

  • Pratt Cancer Center of Kansas

    Pratt, Kansas 67124
    United States

    Site Not Available

  • Cancer Center of Kansas - Salina

    Salina, Kansas 67042
    United States

    Site Not Available

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas 67152
    United States

    Site Not Available

  • Associates in Womens Health

    Wichita, Kansas 67203
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A.

    Wichita, Kansas 67208
    United States

    Site Not Available

  • Cancer Center of Kansas, P.A. - Wichita

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas 67156
    United States

    Site Not Available

  • Brainerd Medical Center

    Brainerd, Minnesota 56401
    United States

    Site Not Available

  • Fairview Ridges Hospital

    Burnsville, Minnesota 55337
    United States

    Site Not Available

  • Mercy Hospital

    Coon Rapids, Minnesota 55433
    United States

    Site Not Available

  • CCOP - Duluth

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Miller-Dwan Medical Center

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • St. Mary's - Duluth Clinic Cancer Center

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Fairview Southdale Hospital

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Mercy and Unity Cancer Center at Mercy and Unity Hospitals

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota 55403
    United States

    Site Not Available

  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center

    Robbinsdale, Minnesota 55422
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • CentraCare Clinic - River Campus

    St. Cloud, Minnesota 56303
    United States

    Site Not Available

  • Park Nicollet Clinic

    St. Louis Park, Minnesota 55416
    United States

    Site Not Available

  • United Hospital

    St. Paul, Minnesota 55102
    United States

    Site Not Available

  • Ridgeview Medical Center

    Waconia, Minnesota 55387
    United States

    Site Not Available

  • Rice Memorial Hospital

    Willmar, Minnesota 56201
    United States

    Site Not Available

  • CCOP - Montana Cancer Consortium

    Billings, Montana 59101
    United States

    Site Not Available

  • Great Falls Clinic

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Sletten Regional Cancer Institute

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Fremont Area Medical Center

    Fremont, Nebraska 68025
    United States

    Site Not Available

  • Bryan LGH Medical Center West

    Lincoln, Nebraska 68502
    United States

    Site Not Available

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • St. Elizabeth Regional Medical Center

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Bergan Mercy Medical Center

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska 68106
    United States

    Site Not Available

  • Cancer Center at Creighton University Medical Center

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Immanuel Medical Center

    Omaha, Nebraska 68122
    United States

    Site Not Available

  • Midlands Cancer Center at Midlands Community Hospital

    Papillion, Nebraska 68046
    United States

    Site Not Available

  • Rutherford Hospital

    Rutherfordton, North Carolina 28139
    United States

    Site Not Available

  • Bismarck Cancer Center

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Medcenter One Health System

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Mid Dakota Clinic, P.C.

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • St. Alexius Medical Center

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota 58201
    United States

    Site Not Available

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822-2001
    United States

    Site Not Available

  • Geisinger Medical Group

    State College, Pennsylvania 16801
    United States

    Site Not Available

  • Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania 18711
    United States

    Site Not Available

  • Rose Ramer Cancer Clinic at Anderson Area Medical Center

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29304
    United States

    Site Not Available

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Avera McKennan Hospital and University Health Center

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Medical X-Ray Center

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota 57104
    United States

    Site Not Available

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