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

Condition(s) targeted: Osteoporosis; Prostate Cancer

Intervention: calcium carbonate (Drug); cholecalciferol (Drug); conjugated estrogens (Drug); risedronate sodium (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: North Central Cancer Treatment Group

Official(s) and/or principal investigator(s):
Charles L. Loprinzi, MD, Study Chair, Affiliation: Mayo Clinic

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.

Official title: Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy: A Phase III Randomized, Placebo-Controlled, Double-Blind Study

Study design: Supportive Care, Randomized, Double-Blind, Placebo Control

Primary outcome: Bone mineral density by test at 1 and 2 years

Secondary outcome: Toxicity questionnaires every 6 months

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona 85259, United States

Mayo Clinic - Jacksonville, Jacksonville, Florida 32224-9980, United States

BroMenn Regional Medical Center, Normal, Illinois 61761, United States

Cancer Treatment Center at Pekin Hospital, Pekin, Illinois 61554, United States

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615, United States

Community Cancer Center, Normal, Illinois 61761, United States

Community Hospital of Ottawa, Ottawa, Illinois 61350, United States

Eureka Hospital, Eureka, Illinois 61530, United States

Galesburg Clinic, Galesburg, Illinois 61401, United States

Galesburg Cottage Hospital, Galesburg, Illinois 61401, United States

Graham Hospital, Canton, Illinois 61520, United States

Hopedale Medical Complex, Hopedale, Illinois 61747, United States

Illinois Valley Community Hospital, Peru, Illinois 61354, United States

InterCommunity Cancer Center of Western Illinois, Galesburg, Illinois 61401, United States

Joliet Oncology Hematology Associates, Limited - West, Joliet, Illinois 60435, United States

Kewanee Hospital, Kewanee, Illinois 61443, United States

Mason District Hospital, Havana, Illinois 62644, United States

McDonough District Hospital, Macomb, Illinois 61455, United States

Memorial Hospital, Carthage, Illinois 62321, United States

Methodist Medical Center of Illinois, Peoria, Illinois 61603, United States

Oncology Hematology Associates of Central Illinois - Ottawa, Ottawa, Illinois 61350, 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

Perry Memorial Hospital, Princeton, Illinois 61356, United States

Proctor Hospital, Peoria, Illinois 61614, United States

Rush-Copley Cancer Care Center, Aurora, Illinois 60507, United States

St. Joseph Medical Center, Bloomington, Illinois 61701, United States

St. Margaret's Hospital, Spring Valley, Illinois 61362, United States

Valley Cancer Center, Spring Valley, Illinois 61362, United States

Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States

Alegent Health Community Memorial Hospital, Missouri Valley, Iowa 51555, United States

Alegent Health Mercy Hospital, Council Bluffs, Iowa 51503, United States

Burgess Health Center, Onawa, Iowa 51040, United States

Cancer Center at Ottumwa Regional Health Center, Ottumwa, Iowa 52501, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309, United States

John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa 50316, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa 50309, United States

McFarland Clinic, P.C., Ames, Iowa 50010, United States

Medical Oncology and Hematology Associates - West Des Moines, West Des Moines, Iowa 50266, 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

Mercy Cancer Center at Mercy Medical Center - North Iowa, Mason City, Iowa 50401, United States

Mercy Capitol Hospital, Des Moines, Iowa 50307, United States

Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States

Saint Anthony Regional Hospital, Carroll, Iowa 51401, United States

Siouxland Hematology-Oncology Associates, Sioux City, Iowa 51101, United States

Siouxland Regional Cancer Center, Sioux City, Iowa 51101-1733, United States

St. Luke's Regional Medical Center, Sioux City, Iowa 51104, United States

Associates in Womens Health, Wichita, Kansas 67203, 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 - Kingman, Kingman, Kansas 67068, United States

Cancer Center of Kansas - Newton, Newton, Kansas 67114, United States

Cancer Center of Kansas - Salina, Salina, Kansas 67042, United States

Cancer Center of Kansas - Wellington, Wellington, Kansas 67152, United States

Cancer Center of Kansas - Winfield, Winfield, Kansas 67156, United States

Cancer Center of Kansas, P.A. - Wichita, Wichita, Kansas 67214, United States

Cancer Center of Kansas, P.A. - El Dorado, El Dorado, Kansas 67042, United States

Cancer Center of Kansas, P.A. - Parsons, Parsons, Kansas 67357, United States

Cancer Center of Kansas, P.A., Wichita, Kansas 67208, United States

CCOP - Wichita, Wichita, Kansas 67214, United States

Pratt Cancer Center of Kansas, Pratt, Kansas 67124, United States

Southwest Medical Center, Liberal, Kansas 67901, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas 67214, United States

Brainerd Medical Center, Brainerd, Minnesota 56401, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

CentraCare Clinic - River Campus, St. Cloud, Minnesota 56303, United States

Fairview Ridges Hospital, Burnsville, Minnesota 55337, United States

Fairview Southdale Hospital, Edina, Minnesota 55435, 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

Mercy and Unity Cancer Center at Mercy and Unity Hospitals, Fridley, Minnesota 55432, United States

Mercy Hospital, Coon Rapids, Minnesota 55433, United States

Miller-Dwan Medical Center, Duluth, Minnesota 55805, United States

Park Nicollet Clinic, St. Louis Park, Minnesota 55416, United States

Rice Memorial Hospital, Willmar, Minnesota 56201, United States

Ridgeview Medical Center, Waconia, Minnesota 55387, United States

St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota 55805, United States

United Hospital, St. Paul, Minnesota 55102, United States

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis, Minnesota 55403, 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

Bergan Mercy Medical Center, Omaha, Nebraska 68124, United States

Bryan LGH Medical Center West, Lincoln, Nebraska 68502, United States

Cancer Center at Creighton University Medical Center, Omaha, Nebraska 68131, United States

Cancer Resource Center - Lincoln, Lincoln, Nebraska 68510, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States

Fremont Area Medical Center, Fremont, Nebraska 68025, United States

Immanuel Medical Center, Omaha, Nebraska 68122, United States

Midlands Cancer Center at Midlands Community Hospital, Papillion, Nebraska 68046, United States

St. Elizabeth Regional Medical Center, Lincoln, Nebraska 68510, United States

Rutherford Hospital, Rutherfordton, North Carolina 28139, United States

Altru Cancer Center at Altru Hospital, Grand Forks, North Dakota 58201, 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

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

Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan S4T 7T1, Canada

Pasqua Hospital, Regina, Saskatchewan S4T 1A5, Canada

CCOP - Upstate Carolina, Spartanburg, South Carolina 29304, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States

Rose Ramer Cancer Clinic at Anderson Area Medical Center, Anderson, South Carolina 29621, 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

Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota 57104, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: November 2002
Last updated: May 23, 2008