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Testosterone Effects on Bone and Frailty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00182871
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 30, 2009
Information provided by:
National Institute on Aging (NIA)

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.

Condition or disease Intervention/treatment Phase
Aging Frailty Osteoporosis Drug: testosterone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Testosterone Effects on Bone and Frailty in Men With Osteoporosis
Study Start Date : November 2001
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Bone density and strength

Secondary Outcome Measures :
  1. Physical performance
  2. quality of life
  3. cognition
  4. lipids
  5. prostate specific antigen
  6. prostate symptoms

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00182871

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United States, Connecticut
Center on Aging, University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
National Institute on Aging (NIA)
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Principal Investigator: Anne Kenny, MD Center on Aging, University of Connecticut Health Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00182871    
Other Study ID Numbers: AG0043
R01AG018887 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: October 30, 2009
Last Verified: October 2009
Keywords provided by National Institute on Aging (NIA):
geriatric medicine
hormone therapy
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Pathologic Processes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs