Clinical trial NCT00527046: Effects Of An Oral Growth Hormone Secretagogue In Older Functionally Limited Adults
Official title: A Randomized, Double Blind, Placebo Controlled, Five Parallel Group Study Of The Effect Of CP-424,391 On Physical Performance And Body Composition In Older Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Aging
Frail Older Adults
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 396
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent increase in lean (non fat) body mass.
timeFrame: Measured by DXA at BL 3, 6, 12, and 24 months
measure: Change in functional performance (speed to climb stairs, walking speed and feet walked in 6 min).
timeFrame: Measured at BL, 3, 6, 12, and 24 months
Secondary outcomes:
measure: Pharmacokinetics, blood hormones and biomarkers
timeFrame: (BL,3,6,12,24 months)
measure: Tape measurement of size of arm and leg muscles, waist, and hip
timeFrame: (BL,3,6,12,24 months)
measure: IGF-1 and GH levels
timeFrame: (1,2,18 months)
measure: Overnight GH profile in a subset
timeFrame: (2,18 months)
measure: Muscle strength
timeFrame: (BL,3,6,12,24 months)
measure: Questionnaires on general health, depression, mental status, sleep and activities of daily living
timeFrame: (BL,3,6,12,24 months)
measure: Other physical performance tests including time to rise from a chair 5 times, balance tests (walking a straight line)
timeFrame: (BL,3,6,12,24 months)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Hamden
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Britain
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Lake Worth
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: White HK, Petrie CD, Landschulz W, MacLean D, Taylor A, Lyles K, Wei JY, Hoffman AR, Salvatori R, Ettinger MP, Morey MC, Blackman MR, Merriam GR; Capromorelin Study Group. Effects of an oral growth hormone secretagogue in older adults. J Clin Endocrinol Metab. 2009 Apr;94(4):1198-206. doi: 10.1210/jc.2008-0632. Epub 2009 Jan 27.