Testosterone Effects on Bone and Frailty in Men With Osteoporosis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Bone density and strength
Study Overview
Brief 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.
Detailed Description
The hypothesis being tested is that testosterone supplementation can increase bone mineral density and specific parameters of frailty in older men with osteoporosis and characteristics of frailty. One hundred and eighty men, age 60 years and older, who have sustained a hip fracture or other fragility fracture following mild to moderate trauma (such as a fall from standing height) in the previous 5 years or who have low femoral neck bone mineral density plus a component of frailty (weight loss, perception of exhaustion, physical strength, physical activity level and walking time) will be randomly assigned to receive either testosterone or placebo, delivered by topical gel applied daily, in a two year double-blind study.
Bone mineral density (BMD) by dual x-ray absorptiometry (DXA), will be performed at baseline and yearly to assess changes in BMD. Blood and urine samples will be collected at baseline and yearly; these tests will be correlated to changes in BMD.
To determine the effects of testosterone on frailty, strength of the upper and lower extremities will be measured every 6 months using the hand-held dynamometer and sitting leg press, respectively. Changes in lean body mass and percent body fat will be measured by total body DXA at baseline, 6 months and then annually. In addition, physical performance, emotional and sexual function, and disability will be assessed also.
The safety of testosterone supplementation on prostate and cardiovascular parameters will also be monitored; participants will be screened for prostate cancer at baseline, 6 months then yearly for 2 years. Fasting lipoprotein levels will be measured yearly while on testosterone replacement, and cardiovascular specific adverse effects such as angina, myocardial infarction, stroke and sudden death will be tracked.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Bone density and strength
Secondary Outcomes
- prostate specific antigen
- prostate symptoms
- quality of life
- cognition
- lipids
- Physical performance