Testosterone Therapy After Hip Fracture in Elderly Women

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: National Institute on Aging (NIA)
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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