Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
Study NCT ID:
NCT00174460
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Result values for the primary outcome measures were revised at the final analysis due to programmatic corrections: age rounded up if \\>6 months past last birthday. Height and height SDS not rounded for final analysis; rounded only for the reports.'}}, 'adverseEventsModule': {'description': 'Safety population=all participants who received at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.', 'eventGroups': [{'id': 'EG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)', 'otherNumAtRisk': 18, 'otherNumAffected': 13, 'seriousNumAtRisk': 18, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.', 'otherNumAtRisk': 15, 'otherNumAffected': 11, 'seriousNumAtRisk': 15, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Autoimmune thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tooth disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Erythema infectiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Febrile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Scarlet fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Open wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Arthritis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nuchal rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Scoliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Attention deficit / hyperactivity disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Facial palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Height Standard Deviation Score (SDS) After 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.099', 'spread': '0.0714', 'groupId': 'OG000'}, {'value': '0.108', 'spread': '0.0783', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.991', 'ciLowerLimit': '0.773', 'ciUpperLimit': '1.210', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1067', 'groupDescription': 'Treatment difference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from analysis of covariance method (ANCOVA) adjusted for baseline height SDS and target height SDS; Last observation carried forward (LOCF).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 1 year (Month 12)', 'description': 'Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS; all randomized subjects who had at least 1 post-baseline efficacy measurement); Control group received Somatropin from Month 12 onwards.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Growth Velocity After 1 Year and After 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Month 12', 'categories': [{'measurements': [{'value': '5.110', 'spread': '0.2623', 'groupId': 'OG000'}, {'value': '0.695', 'spread': '0.2881', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '3.049', 'spread': '0.3546', 'groupId': 'OG000'}, {'value': '3.934', 'spread': '0.3893', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.415', 'ciLowerLimit': '3.605', 'ciUpperLimit': '5.225', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3950', 'groupDescription': 'Treatment difference Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.'}, {'pValue': '0.108', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.884', 'ciLowerLimit': '-1.977', 'ciUpperLimit': '0.208', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5327', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': 'Growth velocity measured as centimeters per year.', 'unitOfMeasure': 'centimeters per year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Growth Velocity SDS After 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.751', 'spread': '0.4716', 'groupId': 'OG000'}, {'value': '5.825', 'spread': '0.5177', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.074', 'ciLowerLimit': '-2.524', 'ciUpperLimit': '0.376', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7089', 'groupDescription': 'Treatment difference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 24', 'description': 'Change in Growth Velocity SDS after 2 years (24 months) where SDS = growth velocity minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).', 'unitOfMeasure': 'centimeters per year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height After 1 Year and After 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Month 12', 'categories': [{'measurements': [{'value': '10.467', 'spread': '0.2439', 'groupId': 'OG000'}, {'value': '5.927', 'spread': '0.2677', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '18.908', 'spread': '0.6507', 'groupId': 'OG000'}, {'value': '14.844', 'spread': '0.7149', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.540', 'ciLowerLimit': '3.789', 'ciUpperLimit': '5.291', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3661', 'groupDescription': 'Treatment difference Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.064', 'ciLowerLimit': '2.049', 'ciUpperLimit': '6.080', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9822', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12, Month 24', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards.', 'anticipatedPostingDate': '2011-03'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height SDS After 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.710', 'spread': '0.1075', 'groupId': 'OG000'}, {'value': '0.991', 'spread': '0.1179', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.719', 'ciLowerLimit': '0.390', 'ciUpperLimit': '1.047', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1606', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline height SDS and target height SDS; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 24', 'description': 'Change in Height SDS after 2 years (24 months) where SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Month 12', 'categories': [{'measurements': [{'value': '-2.20', 'spread': '0.341', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.353', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '-1.30', 'spread': '0.511', 'groupId': 'OG000'}, {'value': '-0.83', 'spread': '0.548', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.70', 'ciLowerLimit': '-3.73', 'ciUpperLimit': '-1.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.497', 'groupDescription': 'Treatment difference Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.'}, {'pValue': '0.537', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-2.04', 'ciUpperLimit': '1.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.758', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Body composition measured as skinfold thickness at tricep in millimeters (mm); measured halfway down the left upper arm with arm hanging in relaxed position at participant's side.", 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Month 12', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.276', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.286', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.231', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.247', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.364', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.405', 'groupDescription': 'Treatment difference Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.'}, {'pValue': '0.506', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '0.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.345', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': 'Body composition measured as subscapular skinfold thickness in millimeters (mm); measured laterally just below the angle of the left scapula.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Month 12', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.783', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.849', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.688', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.774', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.959', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-2.42', 'ciUpperLimit': '2.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.188', 'groupDescription': 'Treatment difference Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.'}, {'pValue': '0.919', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-2.11', 'ciUpperLimit': '2.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.065', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': 'Body composition measured as suprailiac skinfold thickness in millimeters (mm); measured just above the iliac crest in the middle-axillary line.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Volumetric Cortical Bone Mineral Density (BMD) Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and After 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Month 12 (n=2, 6)', 'categories': [{'measurements': [{'value': '-1.055', 'spread': '0.6802', 'groupId': 'OG000'}, {'value': '-0.162', 'spread': '0.3600', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 (n=2, 6)', 'categories': [{'measurements': [{'value': '0.284', 'spread': '0.5023', 'groupId': 'OG000'}, {'value': '-0.433', 'spread': '0.2658', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.336', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.892', 'ciLowerLimit': '-3.158', 'ciUpperLimit': '1.374', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8161', 'groupDescription': 'Treatment difference Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.'}, {'pValue': '0.300', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.717', 'ciLowerLimit': '-0.956', 'ciUpperLimit': '2.391', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6027', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Volumetric Cortical BMD measured as milligrams per cubic millimeter (mg/mm3). BMD (proximal radius) SDS (number of standard deviations a participant's BMD differs from the average BMD of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.", 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.'}, {'type': 'PRIMARY', 'title': 'Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.117', 'spread': '0.4384', 'groupId': 'OG000'}, {'value': '1.502', 'spread': '0.4814', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.615', 'ciLowerLimit': '4.266', 'ciUpperLimit': '6.963', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6591', 'groupDescription': 'Treatment difference', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 1 year (Month 12)', 'description': 'Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).', 'unitOfMeasure': 'centimeters per year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Cross-sectional Area (CSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Month 12 (n=2, 5)', 'categories': [{'measurements': [{'value': '-0.465', 'spread': '0.7799', 'groupId': 'OG000'}, {'value': '0.017', 'spread': '0.4559', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 (n=2, 6)', 'categories': [{'measurements': [{'value': '-0.595', 'spread': '0.7462', 'groupId': 'OG000'}, {'value': '0.609', 'spread': '0.3907', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.653', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.482', 'ciLowerLimit': '-3.558', 'ciUpperLimit': '2.595', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9666', 'groupDescription': 'Treatment difference Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.'}, {'pValue': '0.251', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.205', 'ciLowerLimit': '-3.701', 'ciUpperLimit': '1.292', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8991', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Bone structure Cortical CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.", 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and 2 Years: Total Cross-sectional Area (CSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Month 12 (n=2, 5)', 'categories': [{'measurements': [{'value': '0.375', 'spread': '0.9345', 'groupId': 'OG000'}, {'value': '0.239', 'spread': '0.5537', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 (n=2, 6)', 'categories': [{'measurements': [{'value': '0.243', 'spread': '0.3694', 'groupId': 'OG000'}, {'value': '-0.049', 'spread': '0.1955', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.914', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.135', 'ciLowerLimit': '-3.524', 'ciUpperLimit': '3.795', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.1499', 'groupDescription': 'Treatment difference Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.'}, {'pValue': '0.547', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.292', 'ciLowerLimit': '-0.939', 'ciUpperLimit': '1.522', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4432', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Bone structure Total CSA measured as millimeters squared (mm2). Total CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.", 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Muscle Cross-sectional Area (CSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Month 12 (n=2, 6)', 'categories': [{'measurements': [{'value': '2.084', 'spread': '0.3628', 'groupId': 'OG000'}, {'value': '-0.227', 'spread': '0.1688', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 (n=2, 6)', 'categories': [{'measurements': [{'value': '2.402', 'spread': '0.5221', 'groupId': 'OG000'}, {'value': '0.776', 'spread': '0.2428', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.310', 'ciLowerLimit': '1.049', 'ciUpperLimit': '3.572', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4542', 'groupDescription': 'Treatment difference Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.'}, {'pValue': '0.068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.626', 'ciLowerLimit': '-0.189', 'ciUpperLimit': '3.440', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6536', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Bone structure Muscle CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.", 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Thickness (CT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Cortical Thickness measured as millimeters (mm). CT (proximal radius) SDS (number of standard deviations a participant's CT differs from the average CT of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.", 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards. Cortical thickness was not analyzed as planned.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Marrow Area (MA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Marrow Area measured as millimeters squared (mm2). MA (proximal radius) SDS (number of standard deviations a participant's MA differs from the average MA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.", 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards. Marrow Area was not analyzed as planned.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bone Stability Using pQCT After 1 Year and After 2 Years: Strength-strain Index (SSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Month 12 (n=2, 6)', 'categories': [{'measurements': [{'value': '0.648', 'spread': '0.4224', 'groupId': 'OG000'}, {'value': '0.088', 'spread': '0.2243', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 (n=2, 6)', 'categories': [{'measurements': [{'value': '0.477', 'spread': '0.3925', 'groupId': 'OG000'}, {'value': '0.363', 'spread': '0.2084', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.331', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.560', 'ciLowerLimit': '-0.846', 'ciUpperLimit': '1.965', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5061', 'groupDescription': 'Treatment difference Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.'}, {'pValue': '0.820', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.114', 'ciLowerLimit': '-1.192', 'ciUpperLimit': '1.420', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4703', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Bone stability expressed as polar SSI in cubic millimeters (mm3). SSI (proximal radius) SDS (number of standard deviations a participant's SSI differs from the average SSI of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.", 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Muscle Strength: Hand Grip SDS After 1 Year and After 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Month 12 (n=7, 5)', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.268', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.318', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 (n=7, 6)', 'categories': [{'measurements': [{'value': '1.14', 'spread': '0.218', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '0.236', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.844', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '1.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.420', 'groupDescription': 'Treatment difference Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.'}, {'pValue': '0.519', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.329', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Muscle strength determined by measuring grip force (kilograms) using hand grip dynamometer for participants ≥6 years of age. Baseline and post-baseline SDS values transformed to age and sex specific z-score. Change in hand grip calculated as SDS where SDS = hand grip minus mean (age- and sex-matched reference) divided by SD (age- and sex-matched reference). Positive values are above the average for participant's age and sex; negative values are below the average.", 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants ≥6 years of age with evaluable data at observation for Somatropin and Control Arm, respectively. SDS reference values used were for the right hand but the hand grip strength measured for this study was for the dominant hand (may not have been the right hand).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in Insulin Sensitivity: Somatropin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}], 'classes': [{'title': 'Baseline: tolerant', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: intolerant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: tolerant', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Month 24: intolerant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 24', 'description': 'Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Somatropin treatment group=Month 24). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to \\>140 mg/dL; capillary (blood) with range minimum 120 mg/dL to \\>120 mg/dL; or method not known with range minimum 120 mg/dL to \\>120 mg/dL.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in Insulin Sensitivity: Control Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Baseline: tolerant', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: intolerant', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Month 36: tolerant', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Month 36: intolerant', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 36', 'description': 'Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Control Arm=Month 36). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to \\>140 mg/dL; capillary (blood) with range minimum 120 mg/dL to \\>120 mg/dL; or method not known with range minimum 120 mg/dL to \\>120 mg/dL.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards.'}, {'type': 'SECONDARY', 'title': 'Growth Curve Comparison Based on Height SDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Month 12', 'categories': [{'measurements': [{'value': '-2.260', 'spread': '0.0735', 'groupId': 'OG000'}, {'value': '-3.259', 'spread': '0.0802', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '-1.638', 'spread': '0.1016', 'groupId': 'OG000'}, {'value': '-2.327', 'spread': '0.1122', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.998', 'ciLowerLimit': '0.778', 'ciUpperLimit': '1.219', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1095', 'groupDescription': 'Treatment difference Month 12', 'statisticalMethod': 'Mixed models analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit\\*treatment and target height SDS.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.688', 'ciLowerLimit': '0.382', 'ciUpperLimit': '0.994', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1519', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'Mixed models analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit\\*treatment and target height SDS.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 12, Month 24', 'description': 'Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards. Data for Month 36 (applicable only to the Control Arm) is reported in a separate outcome measure.'}, {'type': 'SECONDARY', 'title': 'Growth Curve Comparison Based on Height SDS: Control Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.794', 'spread': '0.1318', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 36', 'description': 'Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference). Control Arm final visit=Month 36.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards. N=number of subjects with evaluable data at observation. Month 36 visit not applicable to Somatropin treatment group.'}, {'type': 'SECONDARY', 'title': 'Growth Curve Comparison Based on Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'title': 'Month 12', 'categories': [{'measurements': [{'value': '114.228', 'spread': '0.3330', 'groupId': 'OG000'}, {'value': '109.644', 'spread': '0.3733', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '123.351', 'spread': '0.4830', 'groupId': 'OG000'}, {'value': '119.788', 'spread': '0.5255', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.585', 'ciLowerLimit': '3.806', 'ciUpperLimit': '5.363', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3859', 'groupDescription': 'Treatment difference Month 12', 'statisticalMethod': 'Mixed models analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit\\*treatment and target height SDS.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.563', 'ciLowerLimit': '2.134', 'ciUpperLimit': '4.992', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7080', 'groupDescription': 'Treatment difference Month 24', 'statisticalMethod': 'Mixed models analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit\\*treatment and target height SDS.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 12, Month 24', 'description': 'Growth curve comparison with height in centimeters as the dependent variable.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards. Data for Month 36 (applicable only to the Control Arm) is reported in a separate outcome measure.'}, {'type': 'SECONDARY', 'title': 'Growth Curve Comparison Based on Height: Control Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '128.049', 'spread': '0.7821', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 36', 'description': 'Growth curve comparison with height in centimeters as the dependent variable.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; Control group received Somatropin from Month 12 onwards. N=number of subjects with evaluable data at observation. Month 36 visit not applicable to Somatropin treatment group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Received Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Somatropin', 'description': 'The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '5.7', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '5.5', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<4 years', 'categories': [{'measurements': [{'value': '1', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '1', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '2', 'spread': '1.7', 'groupId': 'BG002'}]}]}, {'title': '≥4 years and <8 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': '≥8 years and <12 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': '1 subject in each treatment group was below the age of 4 at screening. However, both of them were 4 years old when treatment began; they did not violate the corresponding inclusion criterion.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2009-03-16', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-03-24', 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Height Standard Deviation Score (SDS) After 1 Year', 'timeFrame': 'Baseline to 1 year (Month 12)', 'description': 'Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).'}, {'measure': 'Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year', 'timeFrame': 'Baseline to 1 year (Month 12)', 'description': 'Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Growth Velocity After 1 Year and After 2 Years', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': 'Growth velocity measured as centimeters per year.'}, {'measure': 'Change From Baseline in Growth Velocity SDS After 2 Years', 'timeFrame': 'Baseline, Month 24', 'description': 'Change in Growth Velocity SDS after 2 years (24 months) where SDS = growth velocity minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).'}, {'measure': 'Change From Baseline in Height After 1 Year and After 2 Years', 'timeFrame': 'Baseline, Month 12, Month 24'}, {'measure': 'Change From Baseline in Height SDS After 2 Years', 'timeFrame': 'Baseline, Month 24', 'description': 'Change in Height SDS after 2 years (24 months) where SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).'}, {'measure': 'Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Body composition measured as skinfold thickness at tricep in millimeters (mm); measured halfway down the left upper arm with arm hanging in relaxed position at participant's side."}, {'measure': 'Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': 'Body composition measured as subscapular skinfold thickness in millimeters (mm); measured laterally just below the angle of the left scapula.'}, {'measure': 'Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': 'Body composition measured as suprailiac skinfold thickness in millimeters (mm); measured just above the iliac crest in the middle-axillary line.'}, {'measure': 'Change From Baseline in Volumetric Cortical Bone Mineral Density (BMD) Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and After 2 Years', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Volumetric Cortical BMD measured as milligrams per cubic millimeter (mg/mm3). BMD (proximal radius) SDS (number of standard deviations a participant's BMD differs from the average BMD of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average."}, {'measure': 'Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Cross-sectional Area (CSA)', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Bone structure Cortical CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average."}, {'measure': 'Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and 2 Years: Total Cross-sectional Area (CSA)', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Bone structure Total CSA measured as millimeters squared (mm2). Total CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average."}, {'measure': 'Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Muscle Cross-sectional Area (CSA)', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Bone structure Muscle CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average."}, {'measure': 'Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Thickness (CT)', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Cortical Thickness measured as millimeters (mm). CT (proximal radius) SDS (number of standard deviations a participant's CT differs from the average CT of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average."}, {'measure': 'Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Marrow Area (MA)', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Marrow Area measured as millimeters squared (mm2). MA (proximal radius) SDS (number of standard deviations a participant's MA differs from the average MA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average."}, {'measure': 'Change From Baseline in Bone Stability Using pQCT After 1 Year and After 2 Years: Strength-strain Index (SSI)', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Bone stability expressed as polar SSI in cubic millimeters (mm3). SSI (proximal radius) SDS (number of standard deviations a participant's SSI differs from the average SSI of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)\\]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average."}, {'measure': 'Change From Baseline in Muscle Strength: Hand Grip SDS After 1 Year and After 2 Years', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': "Muscle strength determined by measuring grip force (kilograms) using hand grip dynamometer for participants ≥6 years of age. Baseline and post-baseline SDS values transformed to age and sex specific z-score. Change in hand grip calculated as SDS where SDS = hand grip minus mean (age- and sex-matched reference) divided by SD (age- and sex-matched reference). Positive values are above the average for participant's age and sex; negative values are below the average."}, {'measure': 'Number of Participants With Change in Insulin Sensitivity: Somatropin', 'timeFrame': 'Baseline, Month 24', 'description': 'Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Somatropin treatment group=Month 24). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to \\>140 mg/dL; capillary (blood) with range minimum 120 mg/dL to \\>120 mg/dL; or method not known with range minimum 120 mg/dL to \\>120 mg/dL.'}, {'measure': 'Number of Participants With Change in Insulin Sensitivity: Control Arm', 'timeFrame': 'Baseline, Month 36', 'description': 'Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Control Arm=Month 36). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to \\>140 mg/dL; capillary (blood) with range minimum 120 mg/dL to \\>120 mg/dL; or method not known with range minimum 120 mg/dL to \\>120 mg/dL.'}, {'measure': 'Growth Curve Comparison Based on Height SDS', 'timeFrame': 'Month 12, Month 24', 'description': 'Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).'}, {'measure': 'Growth Curve Comparison Based on Height SDS: Control Arm', 'timeFrame': 'Month 36', 'description': 'Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference). Control Arm final visit=Month 36.'}, {'measure': 'Growth Curve Comparison Based on Height', 'timeFrame': 'Month 12, Month 24', 'description': 'Growth curve comparison with height in centimeters as the dependent variable.'}, {'measure': 'Growth Curve Comparison Based on Height: Control Arm', 'timeFrame': 'Month 36', 'description': 'Growth curve comparison with height in centimeters as the dependent variable.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth Hormone Therapy', 'Infant, Very Low Birth Weight']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6281273&StudyName=Somatropin%20Therapy%20In%20Children%20Born%20Preterm%20But%20Appropriate%20For%20Gestational%20Age', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:\n\n* Prepubertal caucasian boys between 4 and 10 years of age and girls between 4 and 9 years of age.\n* Girls: Tanner stage 1 breast development\n* Boys: Testis volume \\<= 3ml\n* Tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on growth velocity, insulin sensitivity and body composition).\n* (In case of any signs or symptoms of gonadal puberty a GnRH-Test must decide if the subject is still pubertal.)\n* Height \\<=-2 SD for chronological age (Brandt/Reinken).\n* Growth velocity SDS below 0 SD for chronological age (Brandt/Reinken based on 12+/- 3 months observation period before screening).\n* Premature born defined as \\<=1500 g birth weight.\n* GH sufficiency (GH level \\> 7 ug/l following any routine GH stimulation test).\n* Written informed consent of both parents (legal guardians) and oral/written consent of subject due to age specific information.\n\nExclusion Criteria:\n\nSubjects presenting with any of the following will not be included in the trial:\n\n* Other endocrine diseases except for well substituted hypothyroidism.\n* Severe chronic diseases or medication that might influence linear growth or insulin sensitivity (e.g. Glucocorticoids).\n* Positive GAD and IA-2 antibodies (for type 1 diabetes).\n* History of malignancy\n* Children who meet all of the following 4 criteria:\n* actual body height \\< -2,5 SDS (Brandt/Reinken) and parent adjusted target height \\< -1 SDS (Hermanussen and Cole, 2003)\n* length and/or body weight retardations adjusted to gestational age at birth \\< -2,0 SDS (Lawrence et al., 1989, Voigt et al., 1996)\n* children with chronological age \\> = 4 years and\n* growth velocity \\< 0 SDS during the last year before inclusion.\n* Chromosomal aberrations or syndromes.\n* Suspected non-compliance or impossibility to follow the two or three year treatment schedule, respectively (e.g. social implications).\n* Severe hemiparesis and severe CNS defects\n* Retinopathia \\> third degree or laser treatment as newborns.\n* Participation in any other clinical trial during active treatment phase.\n* Other severe acute or chronic medical or psychiatric condition or clinically relevant laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.'}, 'identificationModule': {'nctId': 'NCT00174460', 'acronym': 'AGA', 'briefTitle': 'Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Somatropin Therapy For Short Children Born Of Premature Gestation, A Controlled, Prospective Randomized, Multicenter Study With An Untreated Control Group.', 'orgStudyIdInfo': {'id': 'A6281273'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Arm', 'interventionNames': ['Drug: Somatropin', 'Other: Control Arm']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm'}], 'interventions': [{'name': 'Somatropin', 'type': 'DRUG', 'description': 'Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. Children randomized to the control group will get the possibility to continue treatment for a further year. The study will end after 2 and 3 years of observation, respectively.', 'armGroupLabels': ['Treatment Arm']}, {'name': 'Control Arm', 'type': 'OTHER', 'description': 'Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. The study will end after 2 and 3 years of observation, respectively. Children randomized to the control group will get the possibility to continue treatment for a further year.', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09009', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '66424', 'city': 'Homburg', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}