Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children

Short Stature Clinical Trial

— MAINTENANCE  

Official title:

Individualizing the Dose of Growth Hormone (GH) to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children Within TR 98-0198-003

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879747
• Other study ID #: NRA 6280003
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2003
• Est. completion date: December 2017

Study information

• Verified date: April 2019
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective was to study whether normal growth velocity can be maintained with adapted GH dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled catch up growth (=difference to target height reached, less than - 0.6 SDS).

Description:

The aim of the trial is to study the effect of adapted GH treatment in order to find an individualized GH dose maintaining normal growth velocity close to target height SDS and normal metabolism after fulfilled catch up growth in prepubertal children treated with individual doses of GH within the trial 98-0198-003 (1). The overall aim is to find for the individual the lowest effective GH dose during maintenance period, maintaining normal growth velocity and metabolism, i.e. a satisfactory biological active dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2017
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• Participated in the 'GH-dose catch-up study' 98- 0198-003.

• Midparental height reached (difference less than 0.6 SDS)

• Prepubertal at start of the study (girls =B 1, boys: testes :<; 3ml).

• Signed written informed consent from the patient's parents (and the child if old enough)

Exclusion Criteria:

• Disease affecting growth other than correctly treated hypothyroidism.

• Incapable of following the study protocol (i.e. bad compliance in the previous study).

• Puberty (> breast stage 2, or testes > 4ml).

• Poor compliance.

Related Conditions & MeSH terms

• Dwarfism
• Short Stature

Intervention

Drug:
• Genotropin
Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Pfizer

References & Publications (2)

Kriström B, Aronson AS, Dahlgren J, Gustafsson J, Halldin M, Ivarsson SA, Nilsson NO, Svensson J, Tuvemo T, Albertsson-Wikland K. Growth hormone (GH) dosing during catch-up growth guided by individual responsiveness decreases growth response variability i — View Citation

Wikland KA, Kriström B, Rosberg S, Svensson B, Nierop AF. Validated multivariate models predicting the growth response to GH treatment in individual short children with a broad range in GH secretion capacities. Pediatr Res. 2000 Oct;48(4):475-84. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Height	Changes in height standard deviation scores (SDS) (calculated as height in cm at start converted to SDS and height in cm after two years in the trial converted to SDS)	start of study to two years after start in the trial
Primary	The Proportion of Children Maintaining Normal Growth Velocity	The proportion of children in the intervention 1 group (=reduced dose) that maintained an individual ?heightSDS within ±0.3 during the first year of the Maintenance trial, compared to the proportion of children in the intervention 2 group (non-reduced dose)	twelve months
Secondary	IGF-I	Delta Insulin-like growth factor-I (24 months after start compared to start of study) expressed as ng/ml and converted to standard deviation scores (SDS) to adjust for gender and age.; A standard deviation score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A mean value within +-0.5 SDS and a range within +-1.0 SDS is a favorable outcome.	start of study to two years after start in the trial
Secondary	Height SDS at Start of Puberty	Height at start of puberty measured as cm and expressed as standard deviation score (SDS) to adjust for age and gender	1-7 years in the trial