Adiposity Rebound Timing in Small for Gestational Age Children Treated With Growth Hormone: Results From LG Growth Study Data.
Ji Hyun Kim, Su Jin Kim, In Hyuk Chung...
https://pubmed.ncbi.nlm.nih.gov/39901524Actively Recruiting
Led by LG Chem · Updated on 2021-02-21
6000
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying the long-term safety and effectiveness of growth hormone treatments called Eutropin Inj. and Eutropin Plus Inj. in children with conditions that affect growth, including Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age, and Idiopathic Short Stature. This observational study aims to understand how these treatments work over time and monitor any side effects. The study observes children who are receiving growth hormone therapy without assigning specific treatments or placebo groups. The research collects data over an extended period, including up to two years after the growth plates (epiphyseal) have closed. This allows researchers to assess the safety by tracking adverse events and evaluate effectiveness by measuring changes in height and growth velocity. Participants will be monitored through regular assessments that measure height differences compared to target heights and baseline measurements. These include evaluations every six months and annually, focusing on height standard deviation scores and growth speed. Safety is closely watched by recording any adverse events during the study period. The total involvement lasts up to two years after the participants' growth plates close, ensuring long-term observations of treatment outcomes.
CONDITIONS
Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children
You may qualify if you...
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years after epiphyseal closure
Participants who have received growth hormone treatment are observed for safety and effectiveness over time.
Visits every 6 months and annually for assessments
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Y
YoungHwan Jang
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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