Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043069
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2002-08-05
Brief Title:
Calcium With or Without Estrogen andor Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy A Phase III Randomized Placebo-Controlled Double-Blind Study
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor risedronate in preventing osteoporosis
PURPOSE Randomized phase III trial to compare the effectiveness of two forms of calcium with or without estrogen andor risedronate in preventing osteoporosis in patients with prostate cancer who are receiving androgen ablation therapy
PURPOSE Randomized phase III trial to compare the effectiveness of two forms of calcium with or without estrogen andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069502 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02482 | REGISTRY | None | None |
| NCI-P02-0229 | None | None | None |