Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058188
Status:
TERMINATED
Last Update Posted:
2020-12-08
First Post:
2003-04-07
Brief Title:
Zolendronate for the Prevention of Bone Loss in Men w Prostate CA on Long-Term Androgen Deprivation
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase III Randomized Study of Zolendronate Bisphosphonate Therapy for the Prevention of Bone Loss in Men With Prostate Cancer Receiving Long-Term Androgen Deprivation
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed by the research committee
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Zoledronate may prevent bone loss associated with long term androgen deprivation therapy It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss
PURPOSE Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy
PURPOSE Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy
Detailed Description:
OBJECTIVES
Compare bone loss in patients receiving long-term androgen deprivation therapy for stage III or IV prostate cancer when treated with supportive care with vs without zoledronate
Compare the percentage change in lumbar spine and hip bone density in patients treated with these regimens
Compare markers of bone formation and resorption in patients treated with these regimens
Compare the incidence of skeletal events pathologic and non-pathologic bone fractures spinal cord compression surgery to bone and radiotherapy to bone in patients treated with these regimens
Compare the incidence of new or progressive bone metastatic disease in patients treated with these regimens
Compare the survival rate of patients treated with these regimens
OUTLINE Patients are stratified according to race black vs other Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily Courses repeat every 3 months for 12 months in the absence of toxicity
Arm II Patients receive oral calcium gluconate and oral cholecalciferol as in arm I
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 72 patients 36 per treatment arm will be accrued for this study
Compare bone loss in patients receiving long-term androgen deprivation therapy for stage III or IV prostate cancer when treated with supportive care with vs without zoledronate
Compare the percentage change in lumbar spine and hip bone density in patients treated with these regimens
Compare markers of bone formation and resorption in patients treated with these regimens
Compare the incidence of skeletal events pathologic and non-pathologic bone fractures spinal cord compression surgery to bone and radiotherapy to bone in patients treated with these regimens
Compare the incidence of new or progressive bone metastatic disease in patients treated with these regimens
Compare the survival rate of patients treated with these regimens
OUTLINE Patients are stratified according to race black vs other Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily Courses repeat every 3 months for 12 months in the absence of toxicity
Arm II Patients receive oral calcium gluconate and oral cholecalciferol as in arm I
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 72 patients 36 per treatment arm will be accrued for this study
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