Aging, Frail Older Adults
Conditions
Brief summary
A 24-month, placebo controlled, double dummy, parallel-design outpatient trial in generally healthy elderly men and women who are at risk of becoming frail.
Interventions
DRUGCP-424,391
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
65 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
65-84 years old, BMI \< 30, at risk for functional decline based on SF-36, Instrumental Activities of Daily Living (per Nagy's), or 2 or more falls in prior 2 years
Exclusion criteria
Significant history or symptoms of acute medical conditions, currently in an exercise program, pain or other conditions that would prevent participating in exercise testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent increase in lean (non fat) body mass. | Measured by DXA at BL 3, 6, 12, and 24 months |
| Change in functional performance (speed to climb stairs, walking speed and feet walked in 6 min). | Measured at BL, 3, 6, 12, and 24 months |
Secondary
| Measure | Time frame |
|---|---|
| IGF-1 and GH levels | (1,2,18 months) |
| Overnight GH profile in a subset | (2,18 months) |
| Pharmacokinetics, blood hormones and biomarkers | (BL,3,6,12,24 months) |
| Questionnaires on general health, depression, mental status, sleep and activities of daily living | (BL,3,6,12,24 months) |
| Other physical performance tests including time to rise from a chair 5 times, balance tests (walking a straight line) | (BL,3,6,12,24 months) |
| Muscle strength | (BL,3,6,12,24 months) |
| Tape measurement of size of arm and leg muscles, waist, and hip | (BL,3,6,12,24 months) |
Countries
United States
Outcome results
None listed