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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 - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Bergan Mercy Medical CenterOmaha, Nebraska  68124
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Fairview Ridges HospitalBurnsville, Minnesota  55337
CCOP - DuluthDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157
Great Falls ClinicGreat Falls, Montana  59405
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - KingmanKingman, Kansas  67068
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Pratt Cancer Center of KansasPratt, Kansas  67124
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A.Wichita, Kansas  67208
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Sletten Regional Cancer InstituteGreat Falls, Montana  59405
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Medical X-Ray CenterSioux Falls, South Dakota  57105
Medcenter One Health SystemBismarck, North Dakota  58501
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Burgess Health CenterOnawa, Iowa  51040
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Brainerd Medical CenterBrainerd, Minnesota  56401
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Bryan LGH Medical Center WestLincoln, Nebraska  68502
St. Elizabeth Regional Medical CenterLincoln, Nebraska  68510
Immanuel Medical CenterOmaha, Nebraska  68122
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
Eureka HospitalEureka, Illinois  61530
Joliet Oncology Hematology Associates, Limited - WestJoliet, Illinois  60435
Oncology Hematology Associates of Central Illinois - OttawaOttawa, Illinois  61350
Mercy HospitalCoon Rapids, Minnesota  55433
Mercy and Unity Cancer Center at Mercy and Unity HospitalsFridley, Minnesota  55432-2799
Park Nicollet ClinicSt. Louis Park, Minnesota  55416
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
McFarland Clinic, P.C.Ames, Iowa  50010
Saint Anthony Regional HospitalCarroll, Iowa  51401
Miller-Dwan Medical CenterDuluth, Minnesota  55805
Rice Memorial HospitalWillmar, Minnesota  56201
Fremont Area Medical CenterFremont, Nebraska  68025-2387
Mid Dakota Clinic, P.C.Bismarck, North Dakota  58501
Geisinger Medical GroupState College, Pennsylvania  16801
Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259
Alegent Health Mercy HospitalCouncil Bluffs, Iowa  51503
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Alegent Health Community Memorial HospitalMissouri Valley, Iowa  51555
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Cancer Center at Creighton University Medical CenterOmaha, Nebraska  68131
Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Cancer Center at Ottumwa Regional Health CenterOttumwa, Iowa  52501