Trial record 8 of 9168 for:    (elderly OR senior) AND (woman OR women OR female) NOT (man OR men OR male)

Testosterone Therapy After Hip Fracture in Elderly Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00280267
First received: January 19, 2006
Last updated: February 3, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Hip Fracture
Testosterone Deficiency
Muscle Weakness
Drug: Testosterone gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Testosterone Therapy After Hip Fracture in Elderly Women

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Serum testosterone levels, drug compliance, symptoms and side effects during the six months of treatment. [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Modified Physical Performance Test Score at 6 months [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • 1-RM muscle strength at 6 months [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Thigh cross-sectional area by MRI at 6 months [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Self-report of ADL function at 6 months [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • SF-36 score (quality of life) at 6 months [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Total and regional bone density by DEXA at 6 months [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: August 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280267

Locations
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
Investigators
Principal Investigator: Ellen F. Binder, MD Washington University School of Medicine, Division of Geriatrics and Nutritional Science
  More Information

No publications provided

Responsible Party: Ellen Binder, MD, Washington University
ClinicalTrials.gov Identifier: NCT00280267     History of Changes
Other Study ID Numbers: R21AG023716
Study First Received: January 19, 2006
Last Updated: February 3, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Muscle Weakness
Paresis
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
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on October 19, 2014