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

NCT02879747 | Completed Phase 2 Results DMC

• 1 other identifier: NRA 6280003
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Short Stature

Keywords

treatment; growth hormone; childhood; short stature

Outcome Measures

Primary Outcomes (1)

• The Proportion of Children Maintaining Normal Growth Velocity

  The proportion of children in the intervention 1 group (=reduced dose) that maintained an individual ΔheightSDS 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 Outcomes (2)

• IGF-I

  start of study to two years after start in the trial

• Height SDS at Start of Puberty

  1-7 years in the trial

Other Outcomes (1)

• Changes in Height

  start of study to two years after start in the trial

Study Arms (2)

Interventional

ACTIVE COMPARATOR

Unchanged dose Genotropin

Drug: Genotropin

Interventional 2

ACTIVE COMPARATOR

reduced dose 50% Genotropin

Drug: Genotropin

Interventions

Genotropin DRUG

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

Interventional; Interventional 2

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead
• Pfizer: collaborator

Related Publications (3)

• Wikland KA, Kristrom 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. doi: 10.1203/00006450-200010000-00010.

  PMID: 11004238 BACKGROUND

• Kristrom 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 in prepubertal children with GH deficiency or idiopathic short stature. J Clin Endocrinol Metab. 2009 Feb;94(2):483-90. doi: 10.1210/jc.2008-1503. Epub 2008 Nov 11.

  PMID: 19001519 RESULT

• Decker R, Albertsson-Wikland K, Kristrom B, Halldin M, Gustafsson J, Nilsson NO, Dahlgren J. GH Dose Reduction Maintains Normal Prepubertal Height Velocity After Initial Catch-Up Growth in Short Children. J Clin Endocrinol Metab. 2019 Mar 1;104(3):835-844. doi: 10.1210/jc.2018-01006.

  PMID: 30339244 DERIVED

MeSH Terms

Conditions

Dwarfism

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr Jovanna Dahlgren, PI and director of Department of Pediatrics
• Organization: Queen Silvia Children´s Hospital and University of Gothenburg

jovanna.dahlgren@gu.se

+46702750233

Study Officials

• Berit Kriström, MD

  Umeå University Hospital

  PRINCIPAL INVESTIGATOR

• Nils-Östen Nilsson, MD

  Halmstad Department of Pediatrics

  PRINCIPAL INVESTIGATOR

• Maria Halldin, MD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

• Sten Ivarsson, MD, Prof

  Malmö Academic Hospital

  PRINCIPAL INVESTIGATOR

• Kerstin Albertsson-Wikland, MD, prof

  Gothenburg University, Departments of pediatrics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 26, 2016
• Study Start: December 1, 2003
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2017
• Last Updated: April 30, 2019
• Results First Posted: April 30, 2019

Record last verified: 2019-04