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The efficacy and safety of growth hormone combined with gonadotropin-releasing hormone analogs in the treatment of short stature children with normal puberty onset: a prospective, multicenter, positive controlled real-world study

The efficacy and safety of growth hormone combined with gonadotropin-releasing hormone analogs in the treatment of short stature children with normal puberty onset: a prospective, multicenter, positive controlled real-world study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104491
Enrollment
Unknown
Registered
2025-06-18
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescence initiates normal short stature

Interventions

GH combined with GnRHa treatment group:NA
GH monotherapy group:NA

Sponsors

The Second Affiliated Hospital of Shantou University Medicine College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
9 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Normal onset of puberty: Girls begin to develop secondary sexual characteristics after the age of 7.5, mainly manifested as breast nodules or menarche after the age of 10.0; Testicular enlargement occurs in boys after the age of 9.0; 2. If the bone age of the child exceeds the actual age by 1 year or more (i.e. BA-CA >= 1 year), according to the bone age height, the average height of normal children of the same age and gender is below -2SD (or below the 3rd percentile); If the difference between the bone age of the patient and their actual age is within ± 1 year (i.e. -1 <= BA-CA < 1 year), according to their actual age and height, they should be below -2SD (or below the 3rd percentile) of the average height of normal children of the same age and gender; 3.10 years old <= boy bone age <= 14 years old, 9 years old <= girl bone age <= 12 years old; 4. Youthful development period: Tanner stage II-III {B2-B3 stage of girls' breasts; Male testicles G2-G3 stage (testicular volume 4-15mL); 5. Uniform dwarfism with normal intellectual development 6. Chromosomes are normal; 7. The epiphysis is not closed; 8. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Cartilage dysplasia, hypothyroidism, constitutional delayed puberty, central precocious puberty, and fast progressive early development; 2. Children with chromosomal disorders, such as Prader Willi syndrome, Silver Russell syndrome, Noonan syndrome, Turner syndrome, etc; Received rhGH and GnRHa treatment within 3.6 months; 4. Children with chronic diseases or long-term use of drugs known to interfere with growth; 5. Insulin like growth factor-1 level >2SDS; 6. The epiphysis has closed; 7. Patients with contraindications for rhGH or GnRHa treatment; 8. Liver and kidney dysfunction (AST/ALT >3 times the upper limit of normal).

Design outcomes

Primary

MeasureTime frame
Predicted Adult Height (PAH);

Secondary

MeasureTime frame
Annual growth rate (GV);Height Standard Deviation Score (Ht SDS);Bone Age (BA);Insulin-like growth factor-1 Standard Deviation Score (IGF-1 SDS);

Countries

China

Contacts

Public ContactHongwu Wang

The Second Affiliated Hospital of Shantou University Medicine College

445918144@qq.com+86 135 9288 5574

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026