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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00043069

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

114

Locations

Arms

Duration (Months)

0.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Prostate Cancer	Dietary Supplement: calcium carbonate Dietary Supplement: cholecalciferol Drug: Estrogen Antagonists Drug: risedronate sodium Other: placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Nov 1, 2002

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm I: calcium + cholecalciferol + placebo + estrogen Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo 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.	Dietary Supplement: calcium carbonate Dietary Supplement: cholecalciferol Drug: Estrogen Antagonists Other: placebo
Experimental: Arm II: calcium + cholecalciferol + risedronate + estrogen Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo 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.	Dietary Supplement: calcium carbonate Dietary Supplement: cholecalciferol Drug: Estrogen Antagonists Drug: risedronate sodium
Placebo Comparator: Arm III: calcium + cholecalciferol + placebo + estrogen Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate placebo 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.	Dietary Supplement: calcium carbonate Dietary Supplement: cholecalciferol Drug: Estrogen Antagonists Other: placebo
Experimental: Arm IV: calcium + cholecalciferol + risedronate + estrogen 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.	Dietary Supplement: calcium carbonate Dietary Supplement: cholecalciferol Drug: Estrogen Antagonists Drug: risedronate sodium

Outcome Measures

Primary Outcome Measures

Bone mineral density by test at 1 and 2 years [Up to 2 years]

Secondary Outcome Measures

Toxicity questionnaires every 6 months [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259
2	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224-9980
3	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60507
4	St. Joseph Medical Center	Bloomington	Illinois	United States	61701
5	Graham Hospital	Canton	Illinois	United States	61520
6	Memorial Hospital	Carthage	Illinois	United States	62321
7	Eureka Hospital	Eureka	Illinois	United States	61530
8	Galesburg Clinic	Galesburg	Illinois	United States	61401
9	Galesburg Cottage Hospital	Galesburg	Illinois	United States	61401
10	InterCommunity Cancer Center of Western Illinois	Galesburg	Illinois	United States	61401
11	Mason District Hospital	Havana	Illinois	United States	62644
12	Hopedale Medical Complex	Hopedale	Illinois	United States	61747
13	Joliet Oncology Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
14	Kewanee Hospital	Kewanee	Illinois	United States	61443
15	McDonough District Hospital	Macomb	Illinois	United States	61455
16	BroMenn Regional Medical Center	Normal	Illinois	United States	61761
17	Community Cancer Center	Normal	Illinois	United States	61761
18	Community Hospital of Ottawa	Ottawa	Illinois	United States	61350
19	Oncology Hematology Associates of Central Illinois - Ottawa	Ottawa	Illinois	United States	61350
20	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois	United States	61554
21	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61603
22	Proctor Hospital	Peoria	Illinois	United States	61614
23	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615
24	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois	United States	61615
25	OSF St. Francis Medical Center	Peoria	Illinois	United States	61637
26	Illinois Valley Community Hospital	Peru	Illinois	United States	61354
27	Perry Memorial Hospital	Princeton	Illinois	United States	61356
28	St. Margaret's Hospital	Spring Valley	Illinois	United States	61362
29	Valley Cancer Center	Spring Valley	Illinois	United States	61362
30	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
31	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
32	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
33	McFarland Clinic, P.C.	Ames	Iowa	United States	50010
34	Saint Anthony Regional Hospital	Carroll	Iowa	United States	51401
35	Alegent Health Mercy Hospital	Council Bluffs	Iowa	United States	51503
36	Mercy Capitol Hospital	Des Moines	Iowa	United States	50307
37	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309
38	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
39	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa	United States	50309
40	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa	United States	50314
41	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
42	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
43	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa	United States	50401
44	Alegent Health Community Memorial Hospital	Missouri Valley	Iowa	United States	51555
45	Burgess Health Center	Onawa	Iowa	United States	51040
46	Cancer Center at Ottumwa Regional Health Center	Ottumwa	Iowa	United States	52501
47	Siouxland Regional Cancer Center	Sioux City	Iowa	United States	51101-1733
48	Siouxland Hematology-Oncology Associates	Sioux City	Iowa	United States	51101
49	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
50	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
51	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa	United States	50266
52	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
53	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
54	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas	United States	67042
55	Cancer Center of Kansas - Kingman	Kingman	Kansas	United States	67068
56	Southwest Medical Center	Liberal	Kansas	United States	67901
57	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
58	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas	United States	67357
59	Pratt Cancer Center of Kansas	Pratt	Kansas	United States	67124
60	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67042
61	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
62	Associates in Womens Health	Wichita	Kansas	United States	67203
63	Cancer Center of Kansas, P.A.	Wichita	Kansas	United States	67208
64	Cancer Center of Kansas, P.A. - Wichita	Wichita	Kansas	United States	67214
65	CCOP - Wichita	Wichita	Kansas	United States	67214
66	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
67	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
68	Brainerd Medical Center	Brainerd	Minnesota	United States	56401
69	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
70	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
71	CCOP - Duluth	Duluth	Minnesota	United States	55805
72	Miller-Dwan Medical Center	Duluth	Minnesota	United States	55805
73	St. Mary's - Duluth Clinic Cancer Center	Duluth	Minnesota	United States	55805
74	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
75	Mercy and Unity Cancer Center at Mercy and Unity Hospitals	Fridley	Minnesota	United States	55432
76	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55403
77	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota	United States	55422
78	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
79	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
80	CentraCare Clinic - River Campus	St. Cloud	Minnesota	United States	56303
81	Park Nicollet Clinic	St. Louis Park	Minnesota	United States	55416
82	United Hospital	St. Paul	Minnesota	United States	55102
83	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
84	Rice Memorial Hospital	Willmar	Minnesota	United States	56201
85	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
86	Great Falls Clinic	Great Falls	Montana	United States	59405
87	Sletten Regional Cancer Institute	Great Falls	Montana	United States	59405
88	Fremont Area Medical Center	Fremont	Nebraska	United States	68025
89	Bryan LGH Medical Center West	Lincoln	Nebraska	United States	68502
90	Cancer Resource Center - Lincoln	Lincoln	Nebraska	United States	68510
91	St. Elizabeth Regional Medical Center	Lincoln	Nebraska	United States	68510
92	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
93	Immanuel Medical Center	Omaha	Nebraska	United States	68122
94	Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
95	Cancer Center at Creighton University Medical Center	Omaha	Nebraska	United States	68131
96	Midlands Cancer Center at Midlands Community Hospital	Papillion	Nebraska	United States	68046
97	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
98	Bismarck Cancer Center	Bismarck	North Dakota	United States	58501
99	Medcenter One Health System	Bismarck	North Dakota	United States	58501
100	Mid Dakota Clinic, P.C.	Bismarck	North Dakota	United States	58501
101	St. Alexius Medical Center	Bismarck	North Dakota	United States	58501
102	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota	United States	58201
103	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma	United States	74136
104	Geisinger Medical Center	Danville	Pennsylvania	United States	17822-2001
105	Geisinger Medical Group	State College	Pennsylvania	United States	16801
106	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	18711
107	Rose Ramer Cancer Clinic at Anderson Area Medical Center	Anderson	South Carolina	United States	29621
108	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
109	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29304
110	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota	United States	57104
111	Avera McKennan Hospital and University Health Center	Sioux Falls	South Dakota	United States	57105
112	Medical X-Ray Center	Sioux Falls	South Dakota	United States	57105
113	Pasqua Hospital	Regina	Saskatchewan	Canada	S4T 1A5
114	Allan Blair Cancer Centre at Pasqua Hospital	Regina	Saskatchewan	Canada	S4T 7T1