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

Completed

• Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency
• Interventions: Other: No treatment given

• Registration Number: NCT02005198
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-09
• Study Start: 2014-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Survey	No treatment given	-

Primary Outcome Measures

Name	Time	Method
Changes in PGI (Patient Global Impression Scale)	After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment
Changes in CGI (Clinician Global Impression Scale)	After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Princeton, New Jersey, United States