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:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01009905
First received: November 5, 2009
Last updated: January 11, 2013
Last verified: November 2012
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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:
Genetics Home Reference related topics:
combined pituitary hormone deficiency
isolated growth hormone deficiency
metatropic dysplasia
pseudoachondroplasia
MedlinePlus related topics:
Dwarfism
Drug Information available for:
Somatropin
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01009905 History of Changes |
| Other Study ID Numbers: | HGH-2149, U1111-1111-1168 |
| Study First Received: | November 5, 2009 |
| Last Updated: | January 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Dwarfism Dwarfism, Pituitary Hypopituitarism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Genetic Diseases, Inborn Endocrine System Diseases Bone Diseases, Endocrine |
Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013