An observational study in Growth Hormone Disorder and Adult Growth Hormone Deficiency, sponsored by Novo Nordisk A/S. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2015-01-08.
Sponsored by Novo Nordisk A/S · Observational
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.
164 studies on the registry are indexed under Dwarfism, Pituitary; 25 are open to participants now.
This study's enrollment of 387 is above the median of 200 across 37 observational studies indexed under Dwarfism, Pituitary.
Browse Dwarfism, Pituitary studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients with growth hormone deficiency including newly-diagnosed patients, who are considered to need treatment with Norditropin® (somatropin) or already on therapy with Norditropin® (somatropin) are eligible for inclusion in the study
Exclusion Criteria:
Drug: somatropin
Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, and a Quality of Life form is completed by the patient, at visits 1 to 5.
Number and type of suspected serious adverse drug reactions (SADRs) during the study period
Time frame: after 5 years
Number of impaired glucose tolerance events during the study period
Time frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
Number of other types of adverse events (AEs) during the study period
Time frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density)
Time frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
Effects of insulin-like growth factor-1 (IGF-I) levels
Time frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S