Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236002
Status:
TERMINATED
Last Update Posted:
2009-08-12
First Post:
2005-10-11
Brief Title:
Cancer and Osteoporosis Research With Alendronate and Lupron CORAL
Sponsor:
Canadian Urology Research Consortium
Organization:
Canadian Urology Research Consortium
Study Overview
Official Title:
A Phase III Double-blind Randomized Parallel Group Placebo-controlled Study of Oral Fosamax 70 mg Once a Week for the Prevention of Androgen Deprivation Bone Loss in Non-metastatic Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual than anticipated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multi-centerdouble blind randomized phase III placebo controlled study in 250 men with histologically proven prostate cancer with out bone metastases who are beginning ADT therapy and who will receive concomitant treatment with either oral Fosamax 70mg once weekly or placebo for one yearThese men will be treated and follow up for one yearduring which time changes in BMD markers of bone resorption and formation will be monitoredAll patients will receive calcium and vitamin D through out the study
Detailed Description:
This is a phase three multicentre double blind randomize parallel group placebo-controlled study in 250 men with histologically proven cancer without bone metastases who are beginning ADT therapy and who will receive a concomitant treatment with either oral Fosamax 70 mg once a weak n125 or placebo n125 for one year Changes in BMD markers of bone absorption and formation are monitored
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