A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin

This study is conducted in Japan. The aim of the study is to evaluate the efficacy of somatropin (Norditropin®) on adult height (cm) in patients with achondroplasia / hypochondroplasia enrolled in the GH-1941 study (NCT01516229).

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Key information

Conditions

Genetic Disorder Achondroplasia Bone Diseases Bone Diseases, Developmental Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients who were enrolled in the GH-1941 study (1997 to 2006) and expected to theoretically reach the adult height within the study period

Treatment and study plan

Somatropin

Drug

Dosage and administration to be prescribed by the physician as a result of a normal clinical practice.

Primary outcomes

To collect change data of adult height (cm) of patients treated with Norditropin® and evaluate the long-term efficacy

Time frame: At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age

Secondary outcomes

To monitor the patients to see if they undergo lower limb lengthening

Time frame: At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Open-label, Multicenter, Observational, Non-intervention Study to Retrospectively Evaluate the Efficacy of Norditropin® (Adult Height) in Patients With Achondroplasia/Hypochondroplasia Enrolled in the GH-1941 Study [Follow-up Survey]

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Sep 16, 2011
Registry last updated: May 5, 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.

Published trials that share one or more normalized conditions with this study.

Completed