Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy: A Phase III Randomized, Placebo-Controlled, Double-Blind Study
Overview
- Phase
- Phase 3
- Intervention
- calcium carbonate
- Conditions
- Osteoporosis
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 71
- Locations
- 114
- Primary Endpoint
- Bone mineral density by test at 1 and 2 years
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: calcium carbonate
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.
Intervention: cholecalciferol
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.
Intervention: Estrogen Antagonists
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.
Intervention: placebo
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.
Intervention: calcium carbonate
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.
Intervention: cholecalciferol
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.
Intervention: Estrogen Antagonists
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.
Intervention: risedronate sodium
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.
Intervention: calcium carbonate
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.
Intervention: cholecalciferol
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.
Intervention: Estrogen Antagonists
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.
Intervention: placebo
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.
Intervention: calcium carbonate
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.
Intervention: cholecalciferol
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.
Intervention: Estrogen Antagonists
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.
Intervention: risedronate sodium
Outcomes
Primary Outcomes
Bone mineral density by test at 1 and 2 years
Time Frame: Up to 2 years
Secondary Outcomes
- Toxicity questionnaires every 6 months(6 months)