Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer
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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 3 |
| 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 |
- Bone mineral density by test at 1 and 2 years
- Toxicity questionnaires every 6 months
| Study Start Date: | November 2002 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
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 |
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
Show 114 Study Locations| Study Chair: | Charles L. Loprinzi, MD | Mayo Clinic |
More Information
Additional Information:
Publications:
| 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 June 18, 2013