Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT01580605
Status:
COMPLETED
Last Update Posted:
2019-11-12
First Post:
2012-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2011-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-08', 'studyFirstSubmitDate': '2012-04-13', 'studyFirstSubmitQcDate': '2012-04-18', 'lastUpdatePostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Once a year for 5 years'}, {'measure': 'Body composition', 'timeFrame': 'Once a year for 5 years'}, {'measure': 'Waist:Hip Ratio', 'timeFrame': 'Once a year for 5 years'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'Once a year for 5 years'}], 'secondaryOutcomes': [{'measure': 'IGF-1 (Insulin-like growth factor 1) concentration', 'timeFrame': 'Once a year for 5 years'}, {'measure': 'Lipids: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides', 'timeFrame': 'Once a year for 5 years'}, {'measure': 'Dose prescribed', 'timeFrame': 'Once a year for 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth Hormone Disorder', 'Adult Growth Hormone Deficiency']}, 'referencesModule': {'references': [{'pmid': '33290752', 'type': 'DERIVED', 'citation': 'Borson-Chazot F, Chabre O, Salenave S, Klein M, Brac de la Perriere A, Reznik Y, Kerlan V, Hacques E, Villette B. Adherence to growth hormone therapy guidelines in a real-world French cohort of adult patients with growth hormone deficiency. Ann Endocrinol (Paris). 2021 Feb;82(1):59-68. doi: 10.1016/j.ando.2020.11.007. Epub 2020 Dec 5.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Europe. The aim of this study is to extract data from the French National Registry holding information about patients having initiated growth hormone therapy with the objective to describe patients receiving growth hormone therapy, assess efficacy and safety of somatropin (Norditropin® SimpleXx®) and evaluate treatment compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients with growth hormone deficiency and treated with Norditropin® SimpleXx (somatropin) for whom Norditropin® SimpleXx® has been initiated either before or during the registry inclusion period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult with growth hormone deficiency\n* Treated with Norditropin® SimpleXx (somatropin)'}, 'identificationModule': {'nctId': 'NCT01580605', 'briefTitle': 'French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started', 'orgStudyIdInfo': {'id': 'GHDA-1755'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Users of somatropin', 'interventionNames': ['Drug: somatropin']}], 'interventions': [{'name': 'somatropin', 'type': 'DRUG', 'description': 'Data are extracted from the French National Registry "l\'Observatoire National des Prescriptions et Consommations de Médicaments" to where physicians report data about growth hormone treatment', 'armGroupLabels': ['Users of somatropin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69394', 'city': 'Lyon', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}