NCT00280267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

Enrollment Period

2.3 years

First QC Date

January 19, 2006

Last Update Submit

February 3, 2009

Conditions

Hip FractureTestosterone DeficiencyMuscle Weakness

Keywords

hip fracturetestosteronemuscle weaknessfrail elderlyaging

Outcome Measures

Primary Outcomes (1)

  • Serum testosterone levels, drug compliance, symptoms and side effects during the six months of treatment.

    Six months

Secondary Outcomes (6)

  • Modified Physical Performance Test Score at 6 months

    Six months

  • 1-RM muscle strength at 6 months

    Six months

  • Thigh cross-sectional area by MRI at 6 months

    Six months

  • Self-report of ADL function at 6 months

    Six months

  • SF-36 score (quality of life) at 6 months

    Six months

  • +1 more secondary outcomes

Interventions

Testosterone gelDRUG

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine, Division of Geriatrics and Nutritional Science

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hip FracturesMuscle Weakness

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Ellen F. Binder, MD

    Washington University School of Medicine, Division of Geriatrics and Nutritional Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2006

First Posted

January 20, 2006

Study Start

August 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations

US(1)