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

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