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| 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: | Supportive Care, Randomized, Double-Blind, Placebo Control |
| Official Title: | Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy: A Phase III Randomized, Placebo-Controlled, Double-Blind Study |
| Study Start Date: | November 2002 |
OBJECTIVES:
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.
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
Meets one of the following criteria:
No known osteoporosis or prior osteoporotic fracture
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No coronary artery disease (CAD) with recent myocardial infarction
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Show 114 Study Locations| Study Chair: | Charles L. Loprinzi, MD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000069502, NCCTG-N01C8, NCI-P02-0229 |
| Study First Received: | August 5, 2002 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00043069 History of Changes |
| Health Authority: | United States: Federal Government |
|
osteoporosis stage I prostate cancer stage II prostate cancer stage III prostate cancer |
|
Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Calcium Channel Blockers Urogenital Neoplasms Bone Density Conservation Agents Calcium Carbonate Bone Diseases Hormones Membrane Transport Modulators Estrogens, Conjugated (USP) Neoplasms by Site Musculoskeletal Diseases |
Therapeutic Uses Vitamins Micronutrients Risedronic acid Cholecalciferol Estrogens Growth Substances Osteoporosis Bone Diseases, Metabolic Cardiovascular Agents Genital Diseases, Male Pharmacologic Actions Neoplasms Antacids Prostatic Neoplasms |