Clinical trial NCT00630487: Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Growth Hormone Deficiency
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)
timeFrame: Baseline, 52 weeks
Secondary outcomes:
measure: Change in Visceral Fat Mass in Subgroups
timeFrame: Baseline, 52 weeks, 78 weeks
measure: Change From Baseline in Anthropometric Parameters (Height)
timeFrame: Baseline, 52 weeks, 78 weeks
measure: Change From Baseline in Anthropometric Parameters (Weight)
timeFrame: Baseline, 52 weeks, 78 weeks
measure: Change From Baseline in Anthropometric Parameters (Waist Circumference)
timeFrame: Baseline, 52 weeks, 78 weeks
measure: Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT])
timeFrame: Baseline, Week 52, Week 78
measure: Change From Baseline in Blood Pressure
timeFrame: Baseline, Week 52, Week 78
measure: Change From Baseline in Heart Rate
timeFrame: Baseline, Week 52, Week 78
measure: Change in Executive Function and Memory in Subgroups
timeFrame: Baseline, Week 52, Week 78
measure: Change From Baseline in Safety Laboratory Assessments
timeFrame: Baseline, Week 52, Week 78
measure: Change From Baseline in Homeostasis Model Assessment (HOMA)-Index
timeFrame: Baseline, Week 52, Week 78
measure: Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA)
timeFrame: Baseline, Week 52, Week 78
measure: Change From Baseline in Short Form (36) Health Survey (SF36)
timeFrame: Baseline, Week 52, Week 78
measure: Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D)
timeFrame: Baseline, Week 52, Week 78
measure: Change From Baseline in Cardiovascular Risk Factors
timeFrame: Baseline, Week 52, Week 78
Other outcomes:
Locations:
city: Bad Aibling
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: