Efficacy and safety of anastrozole combined with growth hormone in the treatment of Prader Willi syndrome in boys of large bone age

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900027464

Enrollment

Unknown

Registered

2019-11-14

Start date

2019-12-01

Completion date

Unknown

Last updated

2019-11-18

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

Conditions

Prader-Willi syndrome

Interventions

control group:Single rhGH therapy

observation group:Anastrazole combined with growth hormone therapy

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1) Genetically confirmed PWS patients, including various genetic types; (2) males; (3) older than or equal to 9 years old, and bone age is more than or equal to 2 years old than physiological age, and the final height is predicted to be less than 160cm. (4) Informed consent of parents/guardians. It meets the above requirements.

Exclusion criteria

Exclusion criteria: (1) Complication with other diseases that may affect skeletal development and height, such as 47XYY, renal rickets, low phosphorus rickets, parathyroid dysfunction or Cushing syndrome; (2) severe liver and kidney dysfunction (ALT > 2 times the normal value); (3) severe scoliosis; (4) severe respiratory obstructive apnea; (5) Cardiac echocardiography showed that significant abnormalities of cardiac structure required surgical or interventional treatment or left ventricular ejection fraction < 40%, or ECG abnormalities required intervention; (6) psychiatric patients, or convulsions or epilepsy control poor; (7) diagnosed cancer patients, past history of cancer or other information considered as Patients at high risk of cancer, such as those with a family history of cancer (two or more cancer patients within three generations of their immediate relatives); (8) diabetic patients or abnormal fasting blood glucose, which researchers believe may affect the safety of the subjects; (9) in the use of other drugs that may affect bone development and height, such as glucocorticoids, etc. (10) Drug allergies in this study.

Design outcomes

Primary

Measure	Time frame
height;weight;Sexual development;hepatic and renal function;Fasting blood glucose;blood fat;thyroid function;IGF-1;Dislocation of hip joint;Scoliosis;sex hormone;Coagulation function;Electrolyte;bone density;Polysomnography;bone age;	—

Countries

China

Contacts

Public ContactZou Chaochun

Children's Hospital of Zhejiang University School of Medicine

zcc14@zju.edu.cn+86 15067123060

Outcome results

None listed

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