Testosterone Therapy After Hip Fracture in Elderly Women

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: NCT00280267
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : February 4, 2009
National Institute on Aging (NIA)
Information provided by:
Washington University School of Medicine

Brief Summary:
The purpose of this study is to determine the feasibility of testosterone replacement therapy in frail elderly female hip fracture patients who have testosterone deficiency, and to obtain preliminary information about the effects of testosterone therapy on muscle strength and size, bone density, mobility, daily functioning, and quality of life.

Condition or disease Intervention/treatment Phase
Hip Fracture Testosterone Deficiency Muscle Weakness Drug: Testosterone gel Phase 2

Detailed Description:

Hip fractures are common among elderly women and can have a devastating impact on their ability to remain independent. A significant functional decline following a hip fracture has been documented, and many patients have persistent strength and mobility deficits that impair their capacity for independent function. Such individuals are at high risk for continued supportive services, recurrent injury, and institutionalization. High-risk patients include those with deficits in skeletal muscle strength during the post-fracture period. Age-associated androgen deficiency contributes to deficits in muscle mass and strength that are common in this patient population. The role of testosterone therapy for improving deficits in muscle mass, strength, and functional capacity in the frail elderly is unclear, particularly for elderly women. There is insufficient information regarding tolerability of testosterone therapy, and the appropriate medication dosage and target serum testosterone levels necessary to induces changes in skeletal muscle mass and functional measures in elderly women with physical frailty due to muscle weakness.

The goals of this project are to conduct a randomized, double-blinded, placebo-controlled prospective study to determine the feasibility, tolerability, and safety of 6 months of testosterone therapy in community-dwelling, physically frail, elderly female hip fracture patients. Twenty-seven female hip fracture patients will be recruited, using objective criteria for testosterone deficiency and frailty. We plan to evaluate two dosages of testosterone, administered as a 0.5% topical gel: a physiologic replacement dosage, and a supraphysiologic dosage. We plan to carefully monitor testosterone levels, side effects, biochemical parameters, and factors related to compliance with therapy. We plan to obtain preliminary information regarding the changes in measurements of muscle strength, total score on an Objective Physical Performance Test, total lean body mass by dual energy x-ray absorptiometry (DEXA), thigh cross-sectional areas by magnetic resonance imaging (MRI), and self-reported performance of activities of daily living, and quality of life. These data will be used to develop a full-scale proposal to test the long-term hypothesis that testosterone therapy combined with exercise training can improve physical function after a hip fracture.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Testosterone Therapy After Hip Fracture in Elderly Women
Study Start Date : August 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Serum testosterone levels, drug compliance, symptoms and side effects during the six months of treatment. [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Modified Physical Performance Test Score at 6 months [ Time Frame: Six months ]
  2. 1-RM muscle strength at 6 months [ Time Frame: Six months ]
  3. Thigh cross-sectional area by MRI at 6 months [ Time Frame: Six months ]
  4. Self-report of ADL function at 6 months [ Time Frame: Six months ]
  5. SF-36 score (quality of life) at 6 months [ Time Frame: Six months ]
  6. Total and regional bone density by DEXA at 6 months [ Time Frame: Six months ]

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.

Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria: -female, hip fracture repair within previous 4 months

  • age 65 years and older
  • serum total testosterone level < 30 ng/dl
  • modified Physical Performance Test Score between 13-28
  • able to ambulate 50 ft

Exclusion Criteria: -permanent nursing home residence

  • dementia severe enough to prohibit informed consent
  • clinically significant visual or hearing impairments
  • history of a hormone dependent neoplasia
  • active or unstable cardiopulmonary disease
  • history of sleep apnea
  • elevated liver function tests
  • hematocrit > 51%
  • history of alcohol or substance abuse
  • symptoms of depression severe enough to cause weight loss of >5% in previous 3 months or interfere with daily activities or medication compliance

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): NCT00280267

United States, Missouri
Washington University School of Medicine, Division of Geriatrics and Nutritional Science
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Institute on Aging (NIA)
Principal Investigator: Ellen F. Binder, MD Washington University School of Medicine, Division of Geriatrics and Nutritional Science

Responsible Party: Ellen Binder, MD, Washington University Identifier: NCT00280267     History of Changes
Other Study ID Numbers: R21AG023716 ( U.S. NIH Grant/Contract )
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Keywords provided by Washington University School of Medicine:
hip fracture
muscle weakness
frail elderly

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Muscle Weakness
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents