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Predictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF)

This study has been withdrawn prior to enrollment.
(Participant enrollment was not feasible)
Information provided by (Responsible Party):
Ipsen Identifier:
First received: August 24, 2011
Last updated: December 19, 2013
Last verified: December 2013
The evaluation of a standardized diagnostic test to predict the growth response in a 1 year trial with Growth Hormone (GH) treatment (carried out in the context of regular patient care) in non GH deficient short children with low serum insulin-like growth factor-1 (IGF-1).

Condition Intervention Phase
Idiopathic Short Stature Drug: Nutropin [Somatropin (rDNA origin) for injection] Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictive Value of Baseline and Stimulated Serum IGF-1 and IGFBP-3 During a Dose-escalation IGF-1 Generation Test for the 1 Year Growth Response to Growth Hormone (GH) Therapy in Short Children With Low IGF-1 and a Normal GH Peak in a Provocation Test

Resource links provided by NLM:

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Peak serum IGF-1 level with GH (1.4 mg/m2/day) change from baseline. [ Time Frame: Week 2 ]

Secondary Outcome Measures:
  • Delta IGF-1 SDS on 0.7 & 1.4 mg GH/m2/day [ Time Frame: Baseline, week 2 ]
  • Delta insulin-like growth factor binding protein-3 (IGFBP-3) standard deviation score (SDS) on 0.7 & 1.4 mg GH/m2/day [ Time Frame: Baseline, week 2 ]
  • Delta of the ratio IGF-1:IGFBP-3 SDS on 0.7 mg & 1.4 mg GH/m2/day [ Time Frame: Baseline, week 2 ]
  • Delta of the ratio IGF-1:IGFBP-2 (insulin-like growth factor binding protein-2) SDS on 0.7 mg & 1.4 mg GH/m2/day [ Time Frame: Baseline, week 2 ]
  • Peak IGFBP-3 SDS on 0.7 mg & 1.4 mg GH/m2/day [ Time Frame: Baseline, week 2 ]
  • Peak of the ratio IGF-1:IGFBP-3 SDS on 0.7 mg & 1.4 mg GH/m2/day [ Time Frame: Baseline, week 2 ]
  • Peak of the ratio IGF-1:IGFBP-2 SDS on 0.7 mg & 1.4 mg GH/m2/day [ Time Frame: Baseline, week 2 ]

Enrollment: 0
Study Start Date: May 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NutropinAq Drug: Nutropin [Somatropin (rDNA origin) for injection]
Doses in the diagnostic protocol are 0.7 and 1.4 mg/m2/day, injected by subcutaneous injection at bedtime for 2 weeks, divided by washout periods of preferably 4 weeks (accepted range 4-6 weeks). An additional period of 2 weeks on 2.8 mg/m2/day (after a washout period of 4-6 weeks) will be added if the IGF-I response on either dosage is insufficient (serum IGF-I SDS <0).


Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 2.0 - 9.0 years for females, 2.0 - 10.0 yrs for males.
  • Prepubertal stage (Tanner 1 for breast (B1) in females, or Tanner 1 for genitals (G1) for males).
  • Bone age < 10 'years' (males) or < 9 'years' (females) according to Greulich and Pyle. The bone age will be read by the pediatric endocrinologist responsible for the pre-study screening visit.
  • Height SDS < -2.5 for ethnically adequate references. For children of Dutch or Western European origin the 1997 nation-wide references for Dutch children will be used. For children of Moroccan or Turkish origin, the respective reference charts will be used. For children of other ethnicities, the 1977 North American (NCHS/WHO) reference will be used, as these charts have been accepted by WHO as world-wide standard from the age of 5 years.

Exclusion Criteria:

  • Has a history of hypersensitivity to growth hormone or phenol (conservative added to GH in NutropinAq), or drugs with a similar chemical structure.
  • Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
  • Has a birth weight and/or length below -2 SDS for Swedish reference charts. Patients will not be excluded due to an unknown birth weight or length.
  • Has a known cause of short stature, or any significant concomitant disease that is likely to interfere with growth or with the study schedule/objectives, or is a known contraindication to GH treatment.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01438801

Sponsors and Collaborators
Study Director: Gino Ciotti, MD Ipsen
  More Information

Responsible Party: Ipsen Identifier: NCT01438801     History of Changes
Other Study ID Numbers: A-95-58035-017
Study First Received: August 24, 2011
Last Updated: December 19, 2013

Additional relevant MeSH terms:
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 19, 2017