Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177619
Status:
COMPLETED
Last Update Posted:
2014-02-11
First Post:
2005-09-13
Brief Title:
Prevention of Osteoporosis in Men With Prostate Cancer on Androgen Deprivation Therapy POP Study
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Prevention of Osteoporosis in Men With Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2014-02
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 overall goal of this proposal is to determine the effectiveness and safety of once weekly alendronate Fosamax in the prevention and treatment of osteoporosis in men with prostate cancer on androgen deprivation therapy and to evaluate maintenance of bone mass following termination of therapy after one year
Detailed Description:
While osteoporosis in women is recognized as a major public health problem osteoporosis in men also has a profound clinical impact Men over the age of 75 who sustain hip fractures have a higher mortality than women of the same age 30 versus 9 Hip fractures in men account for one-third of all hip fractures In 1995 male osteoporosis accounted for 27 billion in health care costs -- nearly one-third of the overall cost of osteoporosis Alendronate has been shown to improve bone mass and decrease vertebral fractures in men with osteoporosis
Prostate cancer is the most common visceral malignancy and the second leading cause of death in American men Almost all men who progress to late stage disease are treated with androgen deprivation therapy for life resulting in a 5-fold increased risk of hip fractures and a 13-fold increased risk of all osteoporosis fractures Several studies suggest the merit of inducing androgen deprivation much earlier in the course of therapy for prostate cancer It is therefore quite likely that androgen deprivation strategies will be employed with increasing frequency in patients with less advanced disease resulting in longer life expectancy but greater bone loss
Prostate cancer is the most common visceral malignancy and the second leading cause of death in American men Almost all men who progress to late stage disease are treated with androgen deprivation therapy for life resulting in a 5-fold increased risk of hip fractures and a 13-fold increased risk of all osteoporosis fractures Several studies suggest the merit of inducing androgen deprivation much earlier in the course of therapy for prostate cancer It is therefore quite likely that androgen deprivation strategies will be employed with increasing frequency in patients with less advanced disease resulting in longer life expectancy but greater bone loss
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01DK061536 | NIH | None | httpsreporternihgovquickSearch5R01DK061536 |