Testosterone Effects on Bone and Frailty

Aging Clinical Trial

Official title:

Testosterone Effects on Bone and Frailty in Men With Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182871
• Other study ID #: AG0043
• Secondary ID: R01AG018887
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: October 29, 2009
• Start date: November 2001
• Est. completion date: July 2007

Study information

• Verified date: October 2009
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Frailty
• Osteoporosis

Intervention

Drug:
• testosterone

Locations

Country	Name	City	State
United States	Center on Aging, University of Connecticut Health Center	Farmington	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Kenny AM, Bellantonio S, Gruman CA, Acosta RD, Prestwood KM. Effects of transdermal testosterone on cognitive function and health perception in older men with low bioavailable testosterone levels. J Gerontol A Biol Sci Med Sci. 2002 May;57(5):M321-5. — View Citation

Kenny AM, Prestwood KM, Gruman CA, Fabregas G, Biskup B, Mansoor G. Effects of transdermal testosterone on lipids and vascular reactivity in older men with low bioavailable testosterone levels. J Gerontol A Biol Sci Med Sci. 2002 Jul;57(7):M460-5. — View Citation

Kenny AM, Prestwood KM, Gruman CA, Marcello KM, Raisz LG. Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels. J Gerontol A Biol Sci Med Sci. 2001 May;56(5):M266-72. — View Citation

Morley JE, Perry HM 3rd, Kaiser FE, Kraenzle D, Jensen J, Houston K, Mattammal M, Perry HM Jr. Effects of testosterone replacement therapy in old hypogonadal males: a preliminary study. J Am Geriatr Soc. 1993 Feb;41(2):149-52. — View Citation

Snyder PJ, Peachey H, Hannoush P, Berlin JA, Loh L, Holmes JH, Dlewati A, Staley J, Santanna J, Kapoor SC, Attie MF, Haddad JG Jr, Strom BL. Effect of testosterone treatment on bone mineral density in men over 65 years of age. J Clin Endocrinol Metab. 1999 Jun;84(6):1966-72. — View Citation

Tenover JL. Testosterone and the aging male. J Androl. 1997 Mar-Apr;18(2):103-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone density and strength
Secondary	Physical performance
Secondary	quality of life
Secondary	cognition
Secondary	lipids
Secondary	prostate specific antigen
Secondary	prostate symptoms