Prevention of Osteoporosis in Men With Prostate Cancer
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 $2.7
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Our primary outcome variable will be change in spine bone mineral density over one year and change during the second year (or both years).
Susan L Greenspan, MD
University of Pittsburgh
United States: Food and Drug Administration
5 R01 DK061536
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