{"id":"growth-hormone-replacement-therapy","rwe":[{"pmid":"39971283","year":"2025","title":"Persistence to growth hormone treatment and clinical characteristics of pediatric patients with growth hormone deficiency: A retrospective cohort study of data from the Japan Medical Data Center claims database.","journal":"Endocrine journal"},{"pmid":"39899245","year":"2025","title":"Growth hormone replacement therapy enhances humoral response to COVID-19 mRNA vaccination in patients with adult-onset growth hormone deficiency.","journal":"Journal of endocrinological investigation"},{"pmid":"39215905","year":"2024","title":"Cardiovascular risk and glucocorticoids: a Dutch National Registry of growth hormone treatment in adults with growth hormone deficiency analysis.","journal":"Pituitary"},{"pmid":"38798228","year":"2024","title":"Exploring the sex difference in cardiovascular risk during growth hormone therapy in adults.","journal":"European journal of endocrinology"},{"pmid":"37802712","year":"2023","title":"Impact of long-acting growth hormone replacement therapy in adult growth hormone deficiency: Comparison between adolescent, adult, and elderly patients.","journal":"Best practice & research. Clinical endocrinology & metabolism"}],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT00638053","NCT00630487","NCT01947894","NCT03525587","NCT02243852","NCT00432263","NCT03021941","NCT01616095","NCT00397319","NCT00555009","NCT04198571"],"aliases":[],"patents":[],"pricing":[],"allNames":"growth hormone replacement therapy","offLabel":[],"timeline":[{"date":"2008","type":"negative","milestone":"Phase 3 Initiated","description":"Phase 3 trial (Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency) — Growth Hormone Deficiency. Trial terminated early."},{"date":"2009","type":"negative","milestone":"Phase 4 Initiated","description":"Phase 4 trial (Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury) — Brain Injuries. Trial terminated early."}],"aiSummary":"Growth Hormone Replacement Therapy is a hormone replacement treatment that restores deficient growth hormone levels in patients with growth hormone deficiency. This therapy works by replacing the natural growth hormone that the body fails to produce adequately, promoting normal growth, metabolism, and body composition. Key clinical differentiators include its ability to improve quality of life in adults and facilitate normal growth trajectories in children with documented deficiency.","brandName":"Growth Hormone Replacement Therapy","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"An observational study of patients who are commencing GH replacement as part of their routine NHS cl","explanation":"Growth hormone is a natural substance produced by the pituitary gland that controls growth, metabolism, and body composition throughout life. When the pituitary gland doesn't produce enough growth hormone—a condition called growth hormone deficiency—it can cause stunted growth in children and various metabolic problems in adults, including reduced muscle mass, increased fat accumulation, and decreased energy levels.\n\nGrowth hormone replacement therapy works by providing synthetic growth hormone that mimics the hormone your body should be making naturally. This injected hormone enters the bloodstream and binds to growth hormone receptors throughout the body, stimulating the same biological processes that the natural hormone would trigger. These include promoting bone growth and strength, increasing muscle mass, improving fat breakdown for energy, and normalizing metabolism.\n\nThe therapy is typically administered through regular injections, allowing doctors to carefully adjust doses to match each patient's specific needs. In children, it can restore normal growth patterns and adult height potential. In adults, it helps restore energy levels, improve body composition, increase strength, and enhance overall quality of life. Treatment requires ongoing monitoring to ensure the hormone levels remain in a healthy range and to adjust dosing as needed.","oneSentence":"An observational study of patients who are commencing GH replacement as part of their routine NHS cl","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"growth-hormone-replacement-therapy","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Growth Hormone Deficiency","phase":"discontinued","trialId":"","patients":null,"diseaseId":"infectious-disease","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00638053","phase":"discontinued","title":"A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Tr","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":100,"indication":"Brain Injuries","completionDate":"","primaryEndpoint":"The purpose of this study is to assess the prevalence of GHD in patients who sustain a head injury or suffer a major traumatic event and to evaluate the efficacy of growth hormone (GH) therapy in the "},{"nctId":"NCT00630487","phase":"discontinued","title":"Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":9,"indication":"Growth Hormone Deficiency","completionDate":"2008-10","primaryEndpoint":"The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass."},{"nctId":"NCT01947894","phase":"discontinued","title":"A Prospective Non-Interventional Study Protocol With Primary Data Collection - Assessment Of The Lon","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":377,"indication":"Growth Hormone Deficiency","completionDate":"2018-10","primaryEndpoint":"The purpose of this study is to assess the long term treatment outcomes of Growth Hormone treatment in patients who are prescribed and treated with Genotropin."},{"nctId":"NCT03525587","phase":"discontinued","title":"Development and Validation of a Self-assessment System Based on a Mobile App to Manage Adult Growth ","status":"discontinued","sponsor":"Azienda Ospedaliero-Universitaria di Modena","isPivotal":false,"enrollment":83,"indication":"Growth Hormone Deficiency","completionDate":"2020-06","primaryEndpoint":"Adult Growth Hormone Deficiency (AGHD) is a recognized clinical entity but several barriers concerning patient-clinician communication, inadequate patients' awareness of the disease, low perceived ben"},{"nctId":"NCT02243852","phase":"discontinued","title":"Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth ","status":"discontinued","sponsor":"University of Liverpool","isPivotal":false,"enrollment":0,"indication":"Growth Hormone Deficiency","completionDate":"2015-08","primaryEndpoint":"This study will recruit healthy controls (who have normal GH production and growth hormone levels) and patients identified as having GHD, who are deemed eligible for GH replacement therapy according t"},{"nctId":"NCT00432263","phase":"discontinued","title":"Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":0,"indication":"Brain Injuries","completionDate":"","primaryEndpoint":"To establish the effects of genotropin replacement in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function."},{"nctId":"NCT03021941","phase":"discontinued","title":"Pharmacokinetics, Pharmacodynamics And Safety Study Of Elelyso(tm) In Pediatric Subjects With Type 1","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":0,"indication":"Type 1 Gaucher Disease","completionDate":"2020-06","primaryEndpoint":"In August of 2014, the FDA approved ELELYSO for long-term enzyme replacement therapy (ERT) for pediatric subjects with a confirmed diagnosis of Type 1 Gaucher disease."},{"nctId":"NCT01616095","phase":"discontinued","title":"Effects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and ","status":"discontinued","sponsor":"Slovak Academy of Sciences","isPivotal":false,"enrollment":44,"indication":"Growth Hormone Deficiency","completionDate":"2013-05","primaryEndpoint":"This study is designed as a follow up study to that performed in 2005."},{"nctId":"NCT00397319","phase":"discontinued","title":"Growth Hormone's Effect on the Cardiovascular System","status":"discontinued","sponsor":"Vanderbilt University","isPivotal":false,"enrollment":26,"indication":"Growth Hormone Deficiency","completionDate":"","primaryEndpoint":"To evaluate specific markers of cardiovascular risk before and after growth hormone replacement therapy in a population of growth hormone deficient adults, as compared to an age, gender, and BMI-match"},{"nctId":"NCT00555009","phase":"discontinued","title":"Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":10,"indication":"Brain Injuries","completionDate":"2009-01","primaryEndpoint":"To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury."},{"nctId":"NCT04198571","phase":"discontinued","title":"Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes and Resource Use of A","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":317,"indication":"Community Acquired Pneumonia","completionDate":"2021-07","primaryEndpoint":"MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalized for Community-Acquired Pneumonia (CAP) or Complicate"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL2108078"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Metabolic"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":4,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}