Testosterone Therapy After Hip Fracture in Elderly Women

Muscle Weakness Clinical Trial

Official title:

Testosterone Therapy After Hip Fracture in Elderly Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280267
• Other study ID #: R21AG023716
• Status: Completed
• Phase: Phase 2
• First received: January 19, 2006
• Last updated: February 3, 2009
• Start date: August 2004
• Est. completion date: December 2006

Study information

• Verified date: February 2009
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Muscle Weakness
• Paresis
• Testosterone Deficiency

Intervention

Drug:
• Testosterone gel

Locations

Country	Name	City	State
United States	Washington University School of Medicine, Division of Geriatrics and Nutritional Science	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum testosterone levels, drug compliance, symptoms and side effects during the six months of treatment.		Six months	Yes
Secondary	Modified Physical Performance Test Score at 6 months		Six months	No
Secondary	1-RM muscle strength at 6 months		Six months	No
Secondary	Thigh cross-sectional area by MRI at 6 months		Six months	No
Secondary	Self-report of ADL function at 6 months		Six months	No
Secondary	SF-36 score (quality of life) at 6 months		Six months	No
Secondary	Total and regional bone density by DEXA at 6 months		Six months	No