Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181584
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2005-09-09
Brief Title:
Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-07
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:
The primary objective of this study is to determine whether zoledronic acid Zometa given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer
Detailed Description:
Patients will be randomized into 2 groups At the screening visit a bone mineral density test will be performed to determine if the patient has osteoporosis or not Patients with osteoporosis will be treated with Zometa Patients without osteoporosis will be randomly assigned to receive either Zometa or a placebo
Zometa is administered intravenously over a 15 minute prior once in this one year study
All patients will asked to take an over-the-counter oral calcium 500mg daily and a daily multi-vitamin containing 400-500 IU of vitamin D during the study
All patients will have clinic visits every 3 months for blood tests and to report any side effects they may be experiencing At month 12 a bone mineral density test will be repeated
Zometa is administered intravenously over a 15 minute prior once in this one year study
All patients will asked to take an over-the-counter oral calcium 500mg daily and a daily multi-vitamin containing 400-500 IU of vitamin D during the study
All patients will have clinic visits every 3 months for blood tests and to report any side effects they may be experiencing At month 12 a bone mineral density test will be repeated
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