Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT00280267
Status:
COMPLETED
Last Update Posted:
2009-02-04
First Post:
2006-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testosterone Therapy After Hip Fracture in Elderly Women
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Testosterone Therapy After Hip Fracture in Elderly Women
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: