Efficacy, Metabolism and BMD of the 3-month TP Compared to the 1-month TP in ICPP
NCT Number: NCT06487143
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Central Precocious Puberty
Interventions: DRUG: Triptorelin pamoate（15mg）|DRUG: Triptorelin acetate （3.75mg）
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: CHILD
Enrollment: 134
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-12-30
Locations: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, 510020, China

Summary:
The primary objective of this study is to compare the efficacy of the 3-month formulation and 1-month formulation of triptorelin and to assess the short-term effects of the 3-month formulation of triptorelin on glucose and lipid metabolism, body composition, and bone density in Chinese ICPP patients.

Primary Outcome Measures: The proportion of LH of ≤ 3 IU/L, In the GnRHa stimulation test, triptorelin is administered intravenously at a dose of 0.1 mg/m² (with a maximum dose of 0.1 mg). Blood samples are collected 60 minutes after administration to measure luteinizing hormone (LH) levels.Serum LH levels were measured by electroimmunochemiluminescence assays., 3 months after injection of 3-month TP and 1-month TP
Secondary Outcome Measures: Basal LH（ IU/L),Basal FSH（IU/L), Estradiol (female) (pg/mL)and testosterone (male)(pg/mL), Changes in baseline luteinizing hormone (LH) levels ,follicle-stimulating hormone (FSH), estradiol (E2), and testosterone (T) after treatment compared to baseline.Serum LH, FSH, estradiol and testosterone levels were measured by electroimmunochemiluminescence assays., Month 0, 3 ,6 and 12 after injection of triptorelin 3M and 1M|Tanner stage, Percentage of children with regression or no progression in Tanner staging. Pubertal stage was determined by an experienced pediatric endocrinologist according to the method proposed by Marshall and Tanner., Month 0, 3 ,6 and 12 after injection of triptorelin 3M and 1M|Uterine length (female)（mL) and testicular volume (male)(mL), Changes in uterine length and ovarian volume for girls, and testicular volume for boys. Pelvic ultrasound will be used to measure the uterine length and ovarian dimensions (length, width, and thickness). The ovarian volume will be calculated using the given formula.The Prader orchidometer will be used to measure the testicular volume before and after treatment., Month 0, 3 ,6 and 12 after injection of triptorelin 3M and 1M|Growth velocity (cm/y), Changes in growth velocity (GV) after treatment compared to baseline.Growth velocity (GV) is typically measured as the annual growth rate, which is the increase in height over a year., Month 0, 3 ,6 and 12 after injection of triptorelin 3M and 1M|BA/CA, Changes in bone age (BA) and the ratio of bone age to chronological age (BA/CA) compared to baseline. Bone age determination will be conducted using an X-ray imaging device to capture X-ray images of the hand and wrist. The BA will be interpreted using a standardized AI bone age assessment instrument (Yitu system)., Month 0, 6 and 12 after injection of triptorelin 3M and 1M|PAH(cm), Predicted adult height (PAH) was calculated using the average tables from the Bayley-Pinneau method, Month 0, 6 and 12 after injection of triptorelin 3M and 1M|Body composition, Comparison of body fat percentage after treatment to baseline using Dual-Energy X-ray Absorptiometry (DXA)., Month 0 and 12 after injection of triptorelin 3M and 1M|Bone Mineral Density, Comparison of the lowest T-score among the lumbar spine (L1-L4), total hip, and femoral neck after treatment to baseline using Dual-Energy X-ray Absorptiometry (DXA)., Month 0 and 12 after injection of triptorelin 3M and 1M|BMISDS, Standard deviation scores (SDS) of body mass index (BMI) were calculated using the 2005 growth chart for Chinese children and adolescents aged 0-18 years.Changes in BMI SDS after Treatment Compared to Baseline, Month 0, 6 and 12 after injection of triptorelin 3M and 1M|glucose metabolism, Changes in Fasting Blood Glucose(mmol/L), Fasting Insulin（μU/mL), and HOMA-IR After Treatment Compared to Baseline.HOMA-IR was calculated by (Fasting Insulin(μU/mL)×Fasting Glucose(mmol/L)) minus 22.5., Month 0, 6 and 12 after injection of triptorelin 3M and 1M|lipid metabolism, Changes in Total Cholesterol (TC)(mg/dL) , Low-Density Lipoprotein (LDL) (mg/dL) ,High-Density Lipoprotein (HDL)(mg/dL), Triglycerides (TG) (mg/dL)After Treatment Compared to Baseline., Month 0, 6 and 12 after injection of triptorelin 3M and 1M