Effects Of An Oral Growth Hormone Secretagogue In Older Functionally Limited Adults
Phase 2
Terminated
- Conditions
- AgingFrail Older Adults
- Registration Number
- NCT00527046
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 396
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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) Tape measurement of size of arm and leg muscles, waist, and hip (BL,3,6,12,24 months) Muscle strength (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)
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Seattle, Washington, United States