Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00043069

Purpose

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.

Condition	Intervention	Phase
Osteoporosis Prostate Cancer	Dietary Supplement: calcium carbonate Dietary Supplement: cholecalciferol Drug: conjugated estrogens Drug: risedronate sodium	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy: A Phase III Randomized, Placebo-Controlled, Double-Blind Study

Resource links provided by NLM:

MedlinePlus related topics: Calcium Cancer Dietary Supplements Diets Osteoporosis Prostate Cancer

Drug Information available for: Cholecalciferol Estrogens, conjugated Risedronic acid Risedronate sodium Calcium gluconate Calcium carbonate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Bone mineral density by test at 1 and 2 years

Secondary Outcome Measures:

Toxicity questionnaires every 6 months

Study Start Date:

November 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043069

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Locations

United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224-9980
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Eureka Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States, 61401
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa, Illinois, United States, 61350
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Valley Cancer Center
Spring Valley, Illinois, United States, 61362
United States, Indiana
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Iowa
Alegent Health Community Memorial Hospital
Missouri Valley, Iowa, United States, 51555
Alegent Health Mercy Hospital
Council Bluffs, Iowa, United States, 51503
Burgess Health Center
Onawa, Iowa, United States, 51040
Cancer Center at Ottumwa Regional Health Center
Ottumwa, Iowa, United States, 52501
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
McFarland Clinic, P.C.
Ames, Iowa, United States, 50010
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101-1733
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, United States, 51101
Saint Anthony Regional Hospital
Carroll, Iowa, United States, 51401
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Associates in Womens Health
Wichita, Kansas, United States, 67203
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States, 67042
Pratt Cancer Center of Kansas
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, P.A.
Wichita, Kansas, United States, 67208
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States, 67357
Southwest Medical Center
Liberal, Kansas, United States, 67901
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Minnesota
Brainerd Medical Center
Brainerd, Minnesota, United States, 56401
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
CentraCare Clinic - River Campus
St. Cloud, Minnesota, United States, 56303
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
Fridley, Minnesota, United States, 55432
Park Nicollet Clinic
St. Louis Park, Minnesota, United States, 55416
Miller-Dwan Medical Center
Duluth, Minnesota, United States, 55805
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
United Hospital
St. Paul, Minnesota, United States, 55102
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55403
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Great Falls Clinic
Great Falls, Montana, United States, 59405
Sletten Regional Cancer Institute
Great Falls, Montana, United States, 59405
United States, Nebraska
Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Bryan LGH Medical Center West
Lincoln, Nebraska, United States, 68502
Cancer Center at Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Fremont Area Medical Center
Fremont, Nebraska, United States, 68025
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States, 68046
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
United States, North Carolina
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, North Dakota
Medcenter One Health System
Bismarck, North Dakota, United States, 58501
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center
Bismarck, North Dakota, United States, 58501
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29304
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, United States, 29621
United States, South Dakota
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57104
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 1A5

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles L. Loprinzi, MD

Mayo Clinic

Study ID Numbers:	CDR0000069502, NCCTG-N01C8, NCI-P02-0229
Study First Received:	August 5, 2002
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00043069 History of Changes
Health Authority:	United States: Federal Government