Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01009905
First received: November 5, 2009
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Growth Hormone Disorder
Pituitary Dwarfism
Hypopituitarism
Drug: somatropin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 18000
Study Start Date: June 2002
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: somatropin
Safety and effectiveness data collection in connection with the use of Norditropin® (somatropin) in daily clinical practice

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from both general and specialty practice settings, existing and new users of growth hormones, who have been deemed appropriate to receive Norditropin® as part of routine out-patient care by the prescribing physician.

Criteria

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®
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009905

Locations
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452), MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01009905     History of Changes
Other Study ID Numbers: HGH-2149, U1111-1111-1168
Study First Received: November 5, 2009
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dwarfism, Pituitary
Hypopituitarism
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Endocrine System Diseases
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on November 24, 2014