(verbatim from application) Attention to osteoporosis has largely emphasized women's health, and little attention has focused on the diagnosis and prevention of osteoporotic fractures in men. And yet the disease is also an important problem in men. Tesosterone levels decline with advancing age, and severe testosterone deficiency is associated with low bone mass and fracture. Several epidemiologic studies suggest that low testosterone is associated with low bone mass in older men, but this finding is not consistent. Men with hip fracture are found to be testosterone deficient more often than control subjects. Among men over age 70 with testosterone levels below young normal range, we found differences in bioavailable testosterone accounted for 20 percent of the variance in femoral next bone mineral density (FN BMD) values. Based on these data, testosterone supplementation may be important for bone health in older men. We will test the hypothesis that testosterone supplementation can decrease the risk of subsequent vertebral and non-vertebral fractures in older men with recent hip fracture. We will also evaluate the effects of testosterone on general health and well-being in this group.
The specific aims of the proposed study will be to determine the effect of testosterone supplementation on vertebral and non-vertebral fractures incidence in men, age 60 years and older, who have sustained a recent hip fracture. Two hundred men, age 60 years and older, who have sustained a hip fracture following mild to moderate trauma (such as a fall from a standing height in the previous 2-6 months) will be randomly assigned to receive either long-acting testosterone or placebo injections in a double-blind study. We will ascertain new, non vertebral fracture incidence by structured questionnaire and follow-up radiographic confirmation every 6 months for 36 months, as well as vertebral fracture rates with baseline lateral spine films and yearly follow-up lateral spine films. In addition, bone mineral density (BMD) of the proximal femur, lumbar spine, distal radius and total body by dual x-ray absorptiometry (DXA) will be performed at baseline and yearly for 3 years to assess changes in BMD. In addition, we will determine the effect of testosterone on general health, including physical and cognitive function, cardiovascular risk, body composition and prostate parameters. Various physical and cognitive measures will be assessed, cardiovascular risk will be assessed by lipid profile and body composition from the whole body DXA and prostate parameters will include prostate specific antigen levels, American Urologic Association Prostate Symptom Score and digital rectal examination of the prostate.
