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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043069
• Other study ID #: NCCTG-N01C8
• Secondary ID: NCI-2012-02482NC
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2002
• Last updated: December 5, 2016
• Start date: November 2002
• Est. completion date: January 2010

Study information

• Verified date: December 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2010
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Osteoporosis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• calcium carbonate

• cholecalciferol

Drug:
• Estrogen Antagonists

• risedronate sodium

Other:
• placebo

Locations

Country	Name	City	State
Canada	Allan Blair Cancer Centre at Pasqua Hospital	Regina	Saskatchewan
Canada	Pasqua Hospital	Regina	Saskatchewan
United States	McFarland Clinic, P.C.	Ames	Iowa
United States	Rose Ramer Cancer Clinic at Anderson Area Medical Center	Anderson	South Carolina
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Medcenter One Health System	Bismarck	North Dakota
United States	Mid Dakota Clinic, P.C.	Bismarck	North Dakota
United States	St. Alexius Medical Center	Bismarck	North Dakota
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	Brainerd Medical Center	Brainerd	Minnesota
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Graham Hospital	Canton	Illinois
United States	Saint Anthony Regional Hospital	Carroll	Iowa
United States	Memorial Hospital	Carthage	Illinois
United States	Cancer Center of Kansas - Chanute	Chanute	Kansas
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Alegent Health Mercy Hospital	Council Bluffs	Iowa
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa
United States	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Mercy Capitol Hospital	Des Moines	Iowa
United States	Cancer Center of Kansas - Dodge City	Dodge City	Kansas
United States	CCOP - Duluth	Duluth	Minnesota
United States	Miller-Dwan Medical Center	Duluth	Minnesota
United States	St. Mary's - Duluth Clinic Cancer Center	Duluth	Minnesota
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas
United States	Eureka Hospital	Eureka	Illinois
United States	Fremont Area Medical Center	Fremont	Nebraska
United States	Mercy and Unity Cancer Center at Mercy and Unity Hospitals	Fridley	Minnesota
United States	Galesburg Clinic	Galesburg	Illinois
United States	Galesburg Cottage Hospital	Galesburg	Illinois
United States	InterCommunity Cancer Center of Western Illinois	Galesburg	Illinois
United States	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota
United States	Great Falls Clinic	Great Falls	Montana
United States	Sletten Regional Cancer Institute	Great Falls	Montana
United States	Mason District Hospital	Havana	Illinois
United States	Hopedale Medical Complex	Hopedale	Illinois
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Joliet Oncology Hematology Associates, Limited - West	Joliet	Illinois
United States	Kewanee Hospital	Kewanee	Illinois
United States	Cancer Center of Kansas - Kingman	Kingman	Kansas
United States	Southwest Medical Center	Liberal	Kansas
United States	Bryan LGH Medical Center West	Lincoln	Nebraska
United States	Cancer Resource Center - Lincoln	Lincoln	Nebraska
United States	St. Elizabeth Regional Medical Center	Lincoln	Nebraska
United States	McDonough District Hospital	Macomb	Illinois
United States	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Alegent Health Community Memorial Hospital	Missouri Valley	Iowa
United States	Cancer Center of Kansas - Newton	Newton	Kansas
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Bergan Mercy Medical Center	Omaha	Nebraska
United States	Cancer Center at Creighton University Medical Center	Omaha	Nebraska
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Immanuel Medical Center	Omaha	Nebraska
United States	Burgess Health Center	Onawa	Iowa
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Oncology Hematology Associates of Central Illinois - Ottawa	Ottawa	Illinois
United States	Cancer Center at Ottumwa Regional Health Center	Ottumwa	Iowa
United States	Midlands Cancer Center at Midlands Community Hospital	Papillion	Nebraska
United States	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	Pratt Cancer Center of Kansas	Pratt	Kansas
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Cancer Center of Kansas - Salina	Salina	Kansas
United States	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates	Sioux City	Iowa
United States	Siouxland Regional Cancer Center	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Avera McKennan Hospital and University Health Center	Sioux Falls	South Dakota
United States	Medical X-Ray Center	Sioux Falls	South Dakota
United States	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	St. Margaret's Hospital	Spring Valley	Illinois
United States	Valley Cancer Center	Spring Valley	Illinois
United States	CentraCare Clinic - River Campus	St. Cloud	Minnesota
United States	Park Nicollet Clinic	St. Louis Park	Minnesota
United States	United Hospital	St. Paul	Minnesota
United States	Geisinger Medical Group	State College	Pennsylvania
United States	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Cancer Center of Kansas - Wellington	Wellington	Kansas
United States	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa
United States	Associates in Womens Health	Wichita	Kansas
United States	Cancer Center of Kansas, P.A.	Wichita	Kansas
United States	Cancer Center of Kansas, P.A. - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Rice Memorial Hospital	Willmar	Minnesota
United States	Cancer Center of Kansas - Winfield	Winfield	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Kearns AE, Northfelt DW, Dueck AC, Atherton PJ, Dakhil SR, Rowland KM Jr, Fuloria J, Flynn PJ, Dentchev T, Loprinzi CL. Osteoporosis prevention in prostate cancer patients receiving androgen ablation therapy: placebo-controlled double-blind study of estra — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density by test at 1 and 2 years		Up to 2 years	No
Secondary	Toxicity questionnaires every 6 months		6 months	Yes