Testosterone Effects on Bone and Frailty (NCT00182871) | Clinical Trial Compass
CompletedPhase 4
Testosterone Effects on Bone and Frailty
United States140 participantsStarted 2001-11
Plain-language 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.
Who can participate
Age range
60 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.