Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)

Adult Growth Hormone Deficiency Clinical Trial

Official title:

Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005198
• Other study ID #: NN8640-4123
• Secondary ID: U1111-1146-1750
• Status: Completed
• Phase: N/A
• First received: December 3, 2013
• Last updated: January 4, 2017
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study is conducted in the United States of America (USA). The aim of the study is to assess the minimal important difference (MID) of the TRIM-AGHD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Years to 79 Years

Eligibility

Inclusion Criteria:

• Able to speak read and write English

• GHD (Growth Hormone Deficiency) treatment naïve which is defined as not being on a prescription treatment for their GHD currently and for at least 6 months

• Beginning a new prescription GHD treatment and expected to be on this treatment for GHD for a minimum of 6 months

• GHD of either one of the following criteria: a) Adult onset: subjects who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or traumatic brain injury (TBI), b) Childhood Onset: Subjects who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes

• Confirmed diagnosis of growth hormone deficiency (if a subject satisfies any one of the three following criteria): a) For the insulin tolerance test (ITT) or glucagon test both performed within the last five years: the validated cut-off for GHD in adults is a peak GH response of below 3.0 ng/mL (3 microg/L), b) For growth hormone releasing hormone (GHRH) +Arginine test performed within the last five years: for those subjects with a body mass index (BMI) below 25 kg/m^2, a peak GH below 11 ng/mL (microg /L); for BMI 25-30 kg/m^2, a peak GH below 8 ng/mL (8 microg/L); for BMI above 30 kg/m^2, a peak GH below 4 ng/mL 341 (4 microg/L ), c) Three or more pituitary hormone deficiencies at screening

• Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)

Exclusion Criteria:

• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

• Patients who have been on a prescription medication for treatment of GHD in past 6 months

• Patients with a total Beck Depression Inventory II (BDI-II) score greater than 25

• Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)

• Acute severe illness associated with weight loss in the last 6 months (defined as a loss of more than 5.0% total body weight)

• Active Cushings syndrome within the last 24 months

• Subject with overt diabetes mellitus

• Previous participation in this study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Disorder

Intervention

Other:
• No treatment given
Subject will only fill out a questionnaire when entering the non-interventional study

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in CGI (Clinician Global Impression Scale)		After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment	No
Primary	Changes in PGI (Patient Global Impression Scale)		After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment	No

External Links

•   Clinical Trials at Novo Nordisk