Testosterone Effects on Bone and Frailty

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to assess the effects of testosterone replacement on bone density, muscle strength, physical performance, quality of life and prostate symptoms in men selected for low bone mineral density or fracture and some aspect of frailty.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Men over age 60 years who have sustained a femoral fracture in the preceding 3 years

• Total testosterone levels below 375 ng/dl or bioavailable testosterone levels at least 1.5 SD lower than the young adult mean

• Able to come or be brought to the University of Connecticut Health Center (UCHC) for outpatient visits

Exclusion Criteria:

• Prostate specific antigen level over 4.0 ng/dl or the history of prostate cancer

• Disease of bone metabolism (i.e., Paget's disease, osteomalacia, hyperparathyroidism)

• History of pituitary disease

• History of sleep apnea

• Consumption of more than 3 alcoholic drinks/day

• Use of androgen, estrogen, or DHEA in the preceding year

• Use of antiresorptive agents such as calcitonin or bisphosphonates

• Metastatic or advanced cancer

• Current chemotherapy or radiation treatment

• Plans to move in the next three years

• Advanced liver or renal disease such that the subjects is unlikely to complete the three year intervention

• Hemaglobin >16.5 g/dl

• Bilateral hip replacement or repair