Clinical trial NCT02005198: Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
Official title: Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 98
Sex: ALL
Minimum age (years): 23
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a diagnosis of growth hormone deficiency (GHD), naïve to treatment currently and for at least 6 months prior, who are beginning a new prescription treatment for their GHD. Patients will be selected by sites as per inclusion and exclusion criteria

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in CGI (Clinician Global Impression Scale)
timeFrame: After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment
measure: Changes in PGI (Patient Global Impression Scale)
timeFrame: After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: