{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T21:41:33Z","timestamp":1790804493694,"version":"4.1.0"},"reference-count":29,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2022,4,29]],"date-time":"2022-04-29T00:00:00Z","timestamp":1651190400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Endocrinol."],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>To evaluate the safety and efficacy of daily somatropin (Jintropin<jats:sup>\u00ae<\/jats:sup>), a recombinant human growth hormone, in prepubertal children with ISS in China.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This study was a multicenter, randomized, controlled, open-label, phase 3 study. All subjects were randomized 3:1 to daily somatropin 0.05 mg\/kg\/day or no treatment for 52 weeks. A total of 481 subjects with a mean baseline age of 5.8 years were enrolled in the study. The primary endpoint was change in (\u25b3) height standard deviation score (HT-SDS) for chronological age (CA). Secondary endpoints included \u25b3height from baseline; \u25b3bone age (BA)\/CA; \u25b3height velocity (HV) and \u25b3insulin-like growth factor 1 (IGF-1 SDS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>\u25b3HT-SDS at week 52 was 1.04 \u00b1 0.31 in the treatment group and 0.20 \u00b1 0.33 in the control group (<jats:italic>P<\/jats:italic> &amp;lt; 0.001). At week 52, statistical significance was observed in the treatment group compared with control for \u25b3height (10.19 \u00b1 1.47 cm vs. 5.85 \u00b1 1.80 cm; <jats:italic>P<\/jats:italic> &amp;lt; 0.001), \u25b3BA\/CA (0.04 \u00b1 0.09 vs. 0.004 \u00b1 0.01; <jats:italic>P<\/jats:italic> &amp;lt; 0.001), \u25b3HV (5.17 \u00b1 3.70 cm\/year vs. 0.75 \u00b1 4.34 cm\/year; <jats:italic>P<\/jats:italic> &amp;lt; 0.001), and \u25b3IGF-1 SDS (2.31 \u00b1 1.20 vs. 0.22 \u00b1 0.98; <jats:italic>P<\/jats:italic> &amp;lt; 0.001). The frequencies of treatment-emergent adverse events (TEAEs) were similar for the treatment and the control groups (89.8% vs. 82.4%); most TEAEs were mild to moderate in severity and 23 AEs were considered study-drug related.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Daily subcutaneous administration of somatropin at 0.05 mg\/kg\/day for 52 weeks demonstrated improvement in growth outcomes and was well tolerated with a favorable safety profile.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p><jats:uri>ClinicalTrials.gov<\/jats:uri> (identifier: NCT03635580). URL: <jats:uri>https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03635580<\/jats:uri><\/jats:p><\/jats:sec>","DOI":"10.3389\/fendo.2022.864908","type":"journal-article","created":{"date-parts":[[2022,4,29]],"date-time":"2022-04-29T13:27:20Z","timestamp":1651238840000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":17,"title":["A Randomized Controlled Phase 3 Study on the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Idiopathic Short 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