Testosterone Effects on Bone and Frailty

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00182871
First received: September 12, 2005
Last updated: October 29, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Aging
Frailty
Osteoporosis
Drug: testosterone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Testosterone Effects on Bone and Frailty in Men With Osteoporosis

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Bone density and strength

Secondary Outcome Measures:
  • Physical performance
  • quality of life
  • cognition
  • lipids
  • prostate specific antigen
  • prostate symptoms

Estimated Enrollment: 140
Study Start Date: November 2001
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182871

Locations
United States, Connecticut
Center on Aging, University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
Investigators
Principal Investigator: Anne Kenny, MD Center on Aging, University of Connecticut Health Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00182871     History of Changes
Other Study ID Numbers: AG0043, R01AG18887
Study First Received: September 12, 2005
Last Updated: October 29, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
geriatric medicine
hormone therapy
HT
andropause

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014