Evaluation of Growth Hormone Treatment in adolescence: Effect on body composition, bones, glucose and lipids in patients who were treated with this hormone

Evaluation of GH Growth Hormone (rhGH) Treatment in the transition phase: Impact on body composition, bone metabolism, glucose and lipids in patients who were treated with rhGH

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-29sg4xg

Enrollment

Unknown

Registered

2022-12-30

Start date

2017-05-17

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Osteoporosis

Interventions

This is a randomized, controlled, open study, and as described in the attached project evaluated by the CEP, with a duration of 24 months. Overall 50 adolescents of both sexes, aged 14 to 20 years, fr

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Eligibility

Age

14 Years to 20 Years

Inclusion criteria

Inclusion criteria: both gender; 14 to 20 years of age; growth speed less than 2 cm/year; bone age equal to or greater than 15 years in girls and 16 years in boys; somatropin use for 3 consecutive years

Exclusion criteria

Exclusion criteria: chronic renal failure; type 1 diabetes mellitus; osteopathies; Prader Willi syndrome; chronic use of corticosteroids

Design outcomes

Primary

Measure	Time frame
Expected Outcome 1: It is expected that the GH insufficient subjects who have discontinued treatment show a variation in bone mineral density; we will performe densitometry in all subjects; we will describe the variation at less 3% change at baseline and pos-treatment.	—

Secondary

Measure	Time frame
We do not expected secondary outcome.	—

Countries

Brazil

Contacts

Public ContactValesca Kuba

Universidade de São Paulo

vmkuba@uol.com.br+55112661-0000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)