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Completed

NCT Number: NCT01009905

An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)

This study is conducted in the United States of America (USA). The aim of this observational study is to collect data concerning the treatment outcomes and safety for children and adults who are prescribed Norditropin®. Specific objectives include: 1) developing models defining the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and treatment outcomes, accounting for independent factors such as age, gender and puberty and 2) determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and other factors before treatment to clinical outcomes.

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Key information

Conditions

Growth Hormone Disorder Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases Pituitary Dwarfism

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Plainsboro, New Jersey, 08536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent obtained
  • Children or adult patients treated with Norditropin® for an appropriate condition as prescribed by their physician

Exclusion criteria

  • Patients not being treated with Norditropin®
  • Patients who have discontinued treatment with Norditropin®
  • Known or suspected allergy to Norditropin® or related products
  • Contraindications for somatropin treatment consistent with the Prescribing Information for Norditropin®

Treatment and study plan

Somatropin

Drug

Safety and effectiveness data collection in connection with the use of Norditropin® (somatropin) in daily clinical practice

Primary outcomes

  1. Change in height, measured as the height standard deviation score (HSDS), from the measurement made by the physician at study entry to the most recent clinic observation, end of GH treatment, de-registration, or change of clinic.

    Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.

  2. Change in waist/hip circumference ratio for adult patients

    Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study

Secondary outcomes

  1. Short-term: Height, Height velocity, Height velocity standard deviation score (SDS), predicted adult height, height SDS for bone age, Proportion achieving height SDS > -2 at end of observational duration period

    Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.

  2. Final Height (or Adult height), Final Height SDS, near-adult height, near-adult height SDS, Final Height - Target Height, Final height - predicted adult height, height age

    Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.

  3. Final Height SDS - Target Height SDS, Final height SDS - predicted adult height SDS

    Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.

  4. Proportion achieving HSDS of more than -2 at final height

    Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.

  5. Weight, waist circumference, and hip circumference for adult patients

    Time frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone

Acronym: ANSWER

Important dates

Study start
2002
Primary completion
2016
Study completion
2016
First posted
Nov 9, 2009
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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