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Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency (IGHD)

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00630487
First received: February 28, 2008
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Growth Hormone Deficiency
Drug: Placebo
Drug: Somatropin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in Visceral Fat Mass in Subgroups [ Time Frame: Baseline, 52 weeks, 78 weeks ] [ Designated as safety issue: No ]
    Change in visceral fat mass in subgroups. Subgroup 1: isolated GHD due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH).

  • Change From Baseline in Anthropometric Parameters (Height) [ Time Frame: Baseline, 52 weeks, 78 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Anthropometric Parameters (Weight) [ Time Frame: Baseline, 52 weeks, 78 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Anthropometric Parameters (Waist Circumference) [ Time Frame: Baseline, 52 weeks, 78 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT]) [ Time Frame: Baseline, Week 52, Week 78 ] [ Designated as safety issue: No ]
    Alertness: software-based neuropsychological assessment for response time and errors. Memory: analysis of learning and retention using 5-trial presentation of 15-word list (A), single presentation of interference list (B), 2 postinterference recall trials - 1 immediate, 1 delayed - and recognition of the target words with distractors (C). Performance variables were immediate word span under overload conditions, final acquisition level, amount learned in 5 trials, interference, delayed recall, and recognition (implicit learning).

  • Change From Baseline in Blood Pressure [ Time Frame: Baseline, Week 52, Week 78 ] [ Designated as safety issue: No ]
    Blood pressure was measured seated, the subject's arm supported at the level of the heart, and recorded to the nearest mm Hg. The same arm (preferably the dominant arm) was used throughout the trial. The subject was seated for 5 minutes before the blood pressure was obtained. Use of an automated device could have been used for measuring blood pressure.

  • Change From Baseline in Heart Rate [ Time Frame: Baseline, Week 52, Week 78 ] [ Designated as safety issue: No ]
    The use of an automated device for measuring pulse rate was acceptable, although, when done manually, pulse rate was measured in the brachial/radial artery for at least 30 seconds.

  • Change in Executive Function and Memory in Subgroups [ Time Frame: Baseline, Week 52, Week 78 ] [ Designated as safety issue: No ]
    Change in executive function and memory in subgroups. Subgroup 1: isolated Growth Hormone Deficiency (GHD)due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH). Median reaction time, the total number of errors, the number of omissions and the number of false positive reactions.

  • Change From Baseline in Safety Laboratory Assessments [ Time Frame: Baseline, Week 52, Week 78 ] [ Designated as safety issue: Yes ]
    Prespecified safety laboratory assessments evaluated for change or no change from baseline. Possible responses were Yes/No.

  • Change From Baseline in Homeostasis Model Assessment (HOMA)-Index [ Time Frame: Baseline, Week 52, Week 78 ] [ Designated as safety issue: No ]
    HOMA index is calculated by 1 of 2 methods: HOMA-Index = fasting insulin measured in microunits per milliliter (µU/ml) times fasting glucose measured in milligrams per deciliter mg/dl) divided by 405 or HOMA-Index = fasting insulin (µU/ml) times fasting glucose measured in millimoles per liter (mmol/l) divided by 22.5.

  • Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA) [ Time Frame: Baseline, Week 52, Week 78 ] [ Designated as safety issue: No ]
    Participant self administered questionnaire consisting of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life.

  • Change From Baseline in Short Form (36) Health Survey (SF36) [ Time Frame: Baseline, Week 52, Week 78 ] [ Designated as safety issue: No ]
    Participant self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT). Scale range 0 to 100, higher scores indicate a better health-related quality of life.

  • Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) [ Time Frame: Baseline, Week 52, Week 78 ] [ Designated as safety issue: No ]
    Participant self-administered questionnaire EQ-5D, a 2 part generic health status instrument. The first part consists of 5 descriptors of current health state: mobility, self care, usual activities, pain/discomfort and anxiety/depression. Scores are assigned on a three-level scale (1= no problem, 2= some problem, 3= extreme problem). The second part was an overall rating of the participant's current health state using a 20 cm Visual Analogue Scale (EQ-VAS) with endpoints labelled 'best imaginable health state' and 'worst imaginable health state'.

  • Change From Baseline in Cardiovascular Risk Factors [ Time Frame: Baseline, Week 52, Week 78 ] [ Designated as safety issue: No ]
    Change in values of laboratory tests indicative of possible cardiovascular risk factors: high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, N-terminal pro brain natriuretic peptide)


Enrollment: 9
Study Start Date: May 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Patients of Placebo Group will be treated with placebo sub-cutaneous in the same way as Somatropin during the double blind treatment phase. To maintain blind subject will be measured in the same way as the treatment group for IGF-I- Levels. Central lab will randomize placebo patients to dose change or maintenance of dose. This will ensure continued blinding of the study to patients and personnel.
Active Comparator: Verum Drug: Somatropin
Fixed doses for patients: MALE: < 45y 0,4 mg, > 45y 0,2mg FEMALE: < 45y 0,5mg, >45y 0,3mg. for the first 4 weeks half of the dose will be given. After that dose will be increased to the targeted maintenance dose according to IGF-I Levels +/- 2 SD of age adjusted reference range. In case of side effects dosage will remain on half-dose (during the first 4 weeks) or reduced to half dose (after the first 4 weeks). At week 52 patients have the opportunity to switch to open label study restarting with half the given fixed dose which will be adjusted to full dose after 4 weeks.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630487

Locations
Germany
Pfizer Investigational Site
Bad Aibling, Germany, 83043
Pfizer Investigational Site
Muenchen, Germany, 80804
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00630487     History of Changes
Other Study ID Numbers: A6281282
Study First Received: February 28, 2008
Results First Received: August 3, 2010
Last Updated: February 26, 2013
Health Authority: Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014