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

NCT02005198 | Completed

• 2 other identifiers: NN8640-4123U1111-1146-1750
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth Hormone Disorder; Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (2)

• Changes in CGI (Clinician Global Impression Scale)

  After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment

• Changes in PGI (Patient Global Impression Scale)

  After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment

Study Arms (1)

Survey

Other: No treatment given

Interventions

No treatment given OTHER

Subject will only fill out a questionnaire when entering the non-interventional study

Survey

Eligibility Criteria

• Age: 23 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Princeton, New Jersey, 08540, United States

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 5, 2017

Record last verified: 2017-01

Locations

US (1)