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The problem
Intervention: Once-weekly somatrogon (long-acting growth hormone) treatment at 0.66 mg/kg/week
Who it was tested with: Children with growth hormone deficiency, with 212 patients in extension year 1 and 177 in extension year 2.
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"During the 12-month main study, patients were randomized 1:1 to once-weekly somatrogon (0.66 mg/kg/week) or once-daily somatropin (0.24 mg/kg/week). Patients could then enter an open-label extension (OLE), wherein somatrogon-treated patients continued receiving somatrogon and somatropin-treated patients switched to somatrogon." The randomized main study followed by open-label extension with switchover design provides experimental-tier evidence for sustained efficacy of the intervention.
Open-label design in extension phase means no blinding; attrition from 222 to 177 patients between years 1 and 2; some patients required dose reductions; long-term outcomes beyond 3 years unknown
Across countries and designs
1 study · 0 countries
