Towards a treatment for accelerated maturation in girls testing spiomet in a randomised placebo controlled, multicentre study.

Girls with advanced puberty and accelerated bone maturation. Polycystic Ovary Syndrome (PCOS)

Bone age advancement 0-1 year (X-ray of hand and wrist of the left hand) using an automated method, BoneXpert (Visiana, Denmark).

Clinical variables: weight, height, BMI, waist and hip circumference and their ratio (incide CC), systolic arterial pressure (SAD), diastolic arterial pressure (DBP) and Tanner stage., Endocrine-metabolic variables: 1) insulinaemia [fasting glucose, insulin, HOMA-IR (5)]; 2) IGF-I; 3) gonadotropins (LH, FSH); 4) sex steroids [circulating androgens (total testosterone, androstenedione, SHBG, FAI) and oestradiol]; 5) lipids [total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides]; 6) markers of inflammation, insulin sensitivity and brown adipose tissue activity [ultrasensitive C-reactive protein (usCRP), GDF-15, HMWadiponectin, CXCL14]., Safety markers: blood count, circulating levels of alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyltransferase (GGT), thyroid stimulating hormone (TSH), urea, creatinine, electrolyte panel, vitamin B12, folic acid., Abdominal fat distribution (subcutaneous and visceral area) and liver fat: distribution of abdominal fat and intrahepatic fat shall be analysed by MRI., Additional secondary outcomes: 1) Dietary habits; 2) Tablet acceptability; 3) Adherence study; 4) Adverse events report.

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