Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00003903|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 16, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Prostate Cancer||Procedure: management of therapy complications||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients|
|Study Start Date :||July 1999|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003903
|United States, New York|
|James P. Wilmot Cancer Center|
|Rochester, New York, United States, 14642-0001|
|Study Chair:||Deepak M. Sahasrabudhe, MD||James P. Wilmot Cancer Center|