Testosterone Effects on Bone and Frailty

NCT00182871 | Completed Phase 4

• 2 other identifiers: AG0043R01AG018887
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Frailty; Osteoporosis

Keywords

geriatric medicine; hormone therapy; HT; andropause

Outcome Measures

Primary Outcomes (1)

• Bone density and strength

Secondary Outcomes (6)

• Physical performance

• quality of life

• cognition

• lipids

• prostate specific antigen

Interventions

testosterone DRUG

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

Center on Aging, University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Publications (7)

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

  PMID: 9154502 BACKGROUND

• 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. doi: 10.1111/j.1532-5415.1993.tb02049.x.

  PMID: 8426037 BACKGROUND

• 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. doi: 10.1210/jcem.84.6.5741.

  PMID: 10372695 BACKGROUND

• 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. doi: 10.1093/gerona/56.5.m266.

  PMID: 11320105 BACKGROUND

• 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. doi: 10.1093/gerona/57.5.m321.

  PMID: 11983727 BACKGROUND

• 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. doi: 10.1093/gerona/57.7.m460.

  PMID: 12084809 BACKGROUND

• Kenny AM, Kleppinger A, Annis K, Rathier M, Browner B, Judge JO, McGee D. Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels, low bone mass, and physical frailty. J Am Geriatr Soc. 2010 Jun;58(6):1134-43. doi: 10.1111/j.1532-5415.2010.02865.x.

  PMID: 20722847 DERIVED

MeSH Terms

Conditions

Frailty; Osteoporosis

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Anne Kenny, MD

  Center on Aging, University of Connecticut Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: November 1, 2001
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: October 30, 2009

Record last verified: 2009-10

Locations

US (1)