Statistical analysis
hypoparathyroidism
SECONDARY, HYPOPARATHYROIDISM
Sample size calculations assuming a 70% response rate for TransCon PTH and 15% for placebo for the primary composite endpoint indicated that 68 participants randomized 3:1 to active TransCon PTH versus placebo would have 99% statistical power at Data from clinical assessments were summarized using descriptive statistics. Categorical data were presented using counts and percentages of participants, whereas continuous variables were summarized by mean and standard deviation (SD). All statistical tests were 2‐sided and tested at the statistically significant level of For the primary efficacy endpoint, the Cochran–Mantel Haenszel test stratified by etiology of hypoparathyroidism (postsurgical or other) was used to compare the proportion of participants meeting the composite primary endpoint in the TransCon PTH versus placebo groups. A prespecified sensitivity analysis of the primary composite endpoint permitting no PRN doses of active vitamin D or calcium for 4 weeks before the week 26 visit was also performed. Participants without week 26 albumin‐adjusted serum calcium or with >25% (ie, >7 days) missing diary data of active vitamin D or elemental calcium during the 4 weeks before week 26 were considered non‐responders.Continuous secondary endpoints were analyzed using an analysis of covariance (ANCOVA) model with unequal variance, which included change from baseline for the endpoint of interest as a response variable, treatment assignment and etiology of hypoparathyroidism as fixed factors, and baseline variable of the endpoint as a covariate. For key secondary patient‐reported outcomes (PROs), the ANCOVA model described above was used to test the change from baseline to week 26 between participants treated with TransCon PTH versus placebo in a prespecified sequence. The prespecified sequential testing procedure was applied to control the family‐wise, type 1 error rate for the primary and key secondary endpoints. All statistical analyses were conducted using SAS version 9.4 (SAS Institute, Cary, NC, USA).