Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00043069

Purpose

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	Intervention	Phase
Osteoporosis Prostate Cancer	Dietary Supplement: calcium carbonate Dietary Supplement: cholecalciferol Drug: conjugated estrogens Drug: risedronate sodium	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Calcium Cancer Osteoporosis Prostate Cancer

Drug Information available for: Cholecalciferol Estrogens, conjugated Risedronic acid Risedronate sodium Calcium gluconate Calcium carbonate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Bone mineral density by test at 1 and 2 years

Secondary Outcome Measures:

Toxicity questionnaires every 6 months

Study Start Date:	November 2002
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043069

Show 114 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles L. Loprinzi, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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 estradiol and risedronate: N01C8. Support Care Cancer. 2010 Mar;18(3):321-8. Epub 2009 May 27.

ClinicalTrials.gov Identifier:	NCT00043069 History of Changes
Other Study ID Numbers:	CDR0000069502, NCCTG-N01C8, NCI-P02-0229
Study First Received:	August 5, 2002
Last Updated:	February 18, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

osteoporosis
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:

Osteoporosis
Prostatic Neoplasms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Calcium Carbonate
Cholecalciferol
Risedronic acid
Etidronic Acid

Estrogens, Conjugated (USP)
Estrogens
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012