Prospective, Randomized, Double Blind Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Adult Patients With Isolated Growth Hormone Deficiency (PRO ISO-GHD Study)

Pfizer1 site in 1 country9 target enrollmentMay 2008

ConditionsGrowth Hormone Deficiency

InterventionsPlacebo Somatropin

DrugsPlacebo Somatropin

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Growth Hormone Deficiency
Sponsor: Pfizer
Enrollment: 9
Locations: 1
Primary Endpoint: Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass.

Detailed Description

The study was terminated on 15-Dec-2008 due to poor recruitment. Although 9 Patients were enrolled, no patient was randomized nor treated with somatropin. No safety reasons contributed to the termination.

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

October 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females between 18 and 65 years of age
•Isolated growth hormone deficiency

Exclusion Criteria

•Isolated growth hormone deficiency by childhood onset
•Diabetes mellitus type 1 or 2

Arms & Interventions

Placebo

Intervention: Placebo

Verum

Intervention: Somatropin

Outcomes

Primary Outcomes

Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)

Time Frame: Baseline, 52 weeks

Fat measurements carried out with the subjects lying in a supine position in a MRI scanner. Measurements of regional body fat obtained between the level of the coccygeal bone and the 2nd or 3rd lumbar vertebra.

Secondary Outcomes

Change in Visceral Fat Mass in Subgroups(Baseline, 52 weeks, 78 weeks)
Change From Baseline in Anthropometric Parameters (Height)(Baseline, 52 weeks, 78 weeks)
Change From Baseline in Anthropometric Parameters (Weight)(Baseline, 52 weeks, 78 weeks)
Change From Baseline in Anthropometric Parameters (Waist Circumference)(Baseline, 52 weeks, 78 weeks)
Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT])(Baseline, Week 52, Week 78)
Change From Baseline in Blood Pressure(Baseline, Week 52, Week 78)
Change From Baseline in Heart Rate(Baseline, Week 52, Week 78)
Change in Executive Function and Memory in Subgroups(Baseline, Week 52, Week 78)
Change From Baseline in Safety Laboratory Assessments(Baseline, Week 52, Week 78)
Change From Baseline in Homeostasis Model Assessment (HOMA)-Index(Baseline, Week 52, Week 78)
Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA)(Baseline, Week 52, Week 78)
Change From Baseline in Short Form (36) Health Survey (SF36)(Baseline, Week 52, Week 78)
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D)(Baseline, Week 52, Week 78)
Change From Baseline in Cardiovascular Risk Factors(Baseline, Week 52, Week 78)