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

Novo Nordisk

Status: Completed

Conditions: Adult Growth Hormone Deficiency; Growth Hormone Disorder

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT02005198

NN8640-4123

U1111-1146-1750 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 23 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

98 participants in 1 patient group

Survey

Treatment:

Other: No treatment given