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

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ClinicalTrials.gov Identifier: NCT02005198
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Growth Hormone Disorder Adult Growth Hormone Deficiency Other: No treatment given

Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Group/Cohort Intervention/treatment
Survey Other: No treatment given
Subject will only fill out a questionnaire when entering the non-interventional study




Primary Outcome Measures :
  1. Changes in CGI (Clinician Global Impression Scale) [ Time Frame: After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment ]
  2. Changes in PGI (Patient Global Impression Scale) [ Time Frame: After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment ]


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Ages Eligible for Study:   23 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005198


Locations
United States, New Jersey
Novo Nordisk Investigational Site
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02005198     History of Changes
Other Study ID Numbers: NN8640-4123
U1111-1146-1750 ( Other Identifier: WHO )
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs