The goal of this study is to genrate evidence on long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care
Patients will be treated according to routine clinical practice, and no additional visits, examinations or tests will be required beyond those performed as part of routine clinical practice except for COAs.
Study Type
OBSERVATIONAL
Enrollment
900
No intervention
Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin)
Incidence of Adverse Events and Serious Adverse Events
Time frame: 5 years
Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin)
Near adult height (cm)
Time frame: 5 years
Assess clinical outcome assessments (COAs)
Change in Quality of Life in Short Stature Youth (QoLISSY) scores from baseline through End of Study (QOLISSY scores range on a scale of 0 to 100 with higher scores representing better quality of life. (For both child and parent version))
Time frame: 5 years
Assess clinical outcome assessments (COAs)
Change in Treatment Satisfaction Questionnaire for Medicine (TSQM-9) scores from baseline through End of Study (The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain)
Time frame: 5 years
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Ascendis Investigational Site
Phoenix, Arizona, United States
RECRUITINGAscendis Investigational Site
Orange, California, United States
RECRUITINGAscendis Investigational Site
Sacramento, California, United States
RECRUITINGAscendis Investigational Site
San Francisco, California, United States
RECRUITINGAscendis Pharma Investigational Site
Centennial, Colorado, United States
RECRUITINGAscendis Investigational Site
Washington D.C., District of Columbia, United States
RECRUITINGAscendis Investigational Site
Orlando, Florida, United States
RECRUITINGAscendis Investigational Site
Orlando, Florida, United States
RECRUITINGAscendis Investigational Site
Tampa, Florida, United States
RECRUITINGAscendis Investigational Site
Sandy Springs, Georgia, United States
RECRUITING...and 17 more locations