Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003903
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
1999-11-01
Brief Title:
Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients
Status:
COMPLETED
Status Verified Date:
2013-10
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 Assessing the effect of androgen suppression on bone loss in prostate cancer patients may improve the ability to plan treatment may decrease the risk of fractures and bony pain and may help patients live more comfortably
PURPOSE Clinical trial to determine the effect of androgen suppression on bone loss in patients who have prostate cancer
PURPOSE Clinical trial to determine the effect of androgen suppression on bone loss in patients who have prostate cancer
Detailed Description:
OBJECTIVES
Evaluate the effect of androgen ablation on bone resorption in patients with or without bone metastases secondary to prostate cancer
OUTLINE Patients are stratified according to prior androgen ablation therapy yes vs no and metastatic disease yes vs no
Patients undergo blood work and 24 hour urine collection on day 1 and at week 6-8 Patients who have received androgen ablation therapy and are found to have increased bone resorption undergo a dual energy x-ray absorptiometry DEXA scan
A comparison is made between androgen ablation therapy and bone resorption and if metastases are associated with the two
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study within 9 months
Evaluate the effect of androgen ablation on bone resorption in patients with or without bone metastases secondary to prostate cancer
OUTLINE Patients are stratified according to prior androgen ablation therapy yes vs no and metastatic disease yes vs no
Patients undergo blood work and 24 hour urine collection on day 1 and at week 6-8 Patients who have received androgen ablation therapy and are found to have increased bone resorption undergo a dual energy x-ray absorptiometry DEXA scan
A comparison is made between androgen ablation therapy and bone resorption and if metastases are associated with the two
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study within 9 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G99-1522 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA011198 |
| P30CA011198 | NIH | None | None |
| URCC-U2898 | None | None | None |