Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-02 @ 12:42 AM
Study NCT ID:
NCT00003903
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA011198 | NIH | None | https://reporter.nih.gov/quic… | View |
| URCC-U2898 | None | None | View | |
| NCI-G99-1522 | None | None | View |