EMR200098-008; Prospective, single-cohort, multicentre observational long-therm study in short children born small for gestational age (SGA) after treatment with Saizen (SALTO Study)

Primary objective of the study:
To assess the long-term safety of Saizen® for 10 years after
cessation of treatment, in terms of occurrence of type 2
diabetes mellitus and malignancies, in a minimum of 200
subjects born SGA who received Saizen® for the treatment
of short stature
Secondary objectives of the study:
To assess occurrence of metabolic syndrome
To assess glucose metabolism parameters
To characterize the observed malignancies
To correlate the occurrence of metabolic syndrome and/or
glucose metabolism disorders or malignancy to familial
inheritance
To correlate the occurrence of metabolic syndrome and
glucose metabolism disorders or malignancy to subject
characteristics and medical history.
Study design and plan Prospective, single-cohort, multicentre, multinational
observational long-term follow-up study in subjects born
SGA who received Saizen® for the treatment of short stature.
The study will comprise a 10-year safety follow-up period
after cessation of Saizen® therapy in short children born SGA
who had received Saizen® in the frame of a company
sponsored clinical study or in the post-marketing setting.
The subjects may be enrolled up to 5 years after treatment
cessation.