Effects Of An Oral Growth Hormone Secretagogue In Older Functionally Limited Adults

Phase 2

Terminated

• Conditions: Aging; Frail 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

Study Timeline

• Study Start: 1999-12
• Primary Completion: 2001-10
• Study Completion: 2001-10
• Study First Submitted: 2007-09-06
• Study First Submitted QC: 2007-09-06
• Study First Posted: 2007-09-10
• Status Verified: 2012-01
• Disposition First Submitted: 2012-01-30
• Disposition First Submitted QC: 2012-01-30
• Last Update Submitted: 2012-01-30
• Disposition First Posted: 2012-02-02
• Last Update Posted: 2012-02-02

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

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

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