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


Phase 3
18 Years
N/A
Not Enrolling
Male
Osteoporosis, Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Bone mineral density by test at 1 and 2 years

Principal Investigator

Charles L. Loprinzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000069502

NCT ID:

NCT00043069

Start Date:

November 2002

Completion Date:

Related Keywords:

  • Osteoporosis
  • Prostate Cancer
  • osteoporosis
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Osteoporosis
  • Prostatic Neoplasms

Name

Location

Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Bergan Mercy Medical Center Omaha, Nebraska  68124
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
St. Luke's Regional Medical Center Sioux City, Iowa  51104
Fairview Ridges Hospital Burnsville, Minnesota  55337
CCOP - Duluth Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Methodist Medical Center of Illinois Peoria, Illinois  61636
CCOP - Montana Cancer Consortium Billings, Montana  59101
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Midlands Cancer Center at Midlands Community Hospital Papillion, Nebraska  68128-4157
Great Falls Clinic Great Falls, Montana  59405
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
St. Mary's - Duluth Clinic Cancer Center Duluth, Minnesota  55805
Siouxland Hematology-Oncology Associates Sioux City, Iowa  51101
Siouxland Regional Cancer Center Sioux City, Iowa  51101-1733
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas, P.A. - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas - Kingman Kingman, Kansas  67068
Southwest Medical Center Liberal, Kansas  67901
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas, P.A. - Parsons Parsons, Kansas  67357
Pratt Cancer Center of Kansas Pratt, Kansas  67124
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, P.A. Wichita, Kansas  67208
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas, P.A. - Wichita Wichita, Kansas  67214
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Sletten Regional Cancer Institute Great Falls, Montana  59405
Avera McKennan Hospital and University Health Center Sioux Falls, South Dakota  57105
Medical X-Ray Center Sioux Falls, South Dakota  57105
Medcenter One Health System Bismarck, North Dakota  58501
Oncology/Hematology Associates of Central Illinois, P.C. Peoria, Illinois  61602
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
InterCommunity Cancer Center of Western Illinois Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
Kewanee Hospital Kewanee, Illinois  61443
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
Valley Cancer Center Spring Valley, Illinois  61362
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Burgess Health Center Onawa, Iowa  51040
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Brainerd Medical Center Brainerd, Minnesota  56401
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Bryan LGH Medical Center West Lincoln, Nebraska  68502
St. Elizabeth Regional Medical Center Lincoln, Nebraska  68510
Immanuel Medical Center Omaha, Nebraska  68122
Bismarck Cancer Center Bismarck, North Dakota  58501
St. Alexius Medical Center Bismarck, North Dakota  58502
Eureka Hospital Eureka, Illinois  61530
Joliet Oncology Hematology Associates, Limited - West Joliet, Illinois  60435
Oncology Hematology Associates of Central Illinois - Ottawa Ottawa, Illinois  61350
Mercy Hospital Coon Rapids, Minnesota  55433
Mercy and Unity Cancer Center at Mercy and Unity Hospitals Fridley, Minnesota  55432-2799
Park Nicollet Clinic St. Louis Park, Minnesota  55416
Rose Ramer Cancer Clinic at Anderson Area Medical Center Anderson, South Carolina  29621
McFarland Clinic, P.C. Ames, Iowa  50010
Saint Anthony Regional Hospital Carroll, Iowa  51401
Miller-Dwan Medical Center Duluth, Minnesota  55805
Rice Memorial Hospital Willmar, Minnesota  56201
Fremont Area Medical Center Fremont, Nebraska  68025-2387
Mid Dakota Clinic, P.C. Bismarck, North Dakota  58501
Geisinger Medical Group State College, Pennsylvania  16801
Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale, Arizona  85259
Alegent Health Mercy Hospital Council Bluffs, Iowa  51503
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Alegent Health Community Memorial Hospital Missouri Valley, Iowa  51555
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
Cancer Center at Creighton University Medical Center Omaha, Nebraska  68131
Altru Cancer Center at Altru Hospital Grand Forks, North Dakota  58201
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Cancer Center at Ottumwa Regional Health Center Ottumwa, Iowa  52501