Health Condition 1: E250- Congenital adrenogenital disordersassociated with enzyme deficiency
Conditions
Interventions
Intervention1: letrozole: 2.5 mg OD oral for 12 months
Control Intervention1: Placebo: Identical appearing placebo tablet OD for 12 months
Sponsors
Sharan Thangaraju
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children with genetically confirmed 21-hydroxylase deficiency 2. Bone age advancement by at least 12 months 3. Stable glucocorticoid requirement, No glucocorticoid dose adjustment greater than 20 percent over the past 6 months
Exclusion criteria
Exclusion criteria: 1. Advanced puberty, tanner stage more than III at baseline 2. Previous and current use of anti-androgens, growth hormone, aromatase inhibitors, and GnRH analogs 3. Severe co-morbidities like renal failure, cardiac disease 4. Poor disease control: More than 2 values of 17-OHP greater than 20 ng per mL in the last 6 months 5. Known hypersensitivity to letrozole or its excipients 6. Radiological evidence of closed epiphysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Predicted final adult heightTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone age and corrected height Z scoreTimepoint: 12 months;Biochemical parameters (17-OHP, Testosterone, Estradiol, DHEAS)Timepoint: 3, 6, 9, 12 months;Bone mineral density and visceral adiposityTimepoint: 12 months | — |
Countries
India
Contacts
Public ContactSharan Thangaraju
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed