Clinical Studies - EDMARC

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Clinical Studies at EDMaRC
EDMaRC is affiliated at Department of Growth and Reproduction at Copenhagen University Hospital-Rigshospitalet, which is a EU expert centre for rare endocrine diseases (ENDO-ERN). The department is a tertiary referal centre for specialised paediatric endocrinology and medical andrology and a certified EAA training centre. Clinical studies in EDMaRC include local, national and international clinical trials
Ongoing Clinical Studies
The NorthEuropean Small-for-Gestational-Age (SGA) Study - NESGAS
NESGAS is a multicenter, randomized, parallel group trial (EudraCT 2005–001507–19) of GH treatment in short SGA-born prepubertal children. For more information see here.
Klinefelter syndrome – the effect of Testosterone treatment In PubertY (TIPY) - A randomized, double-blind placebo-controlled intervention study
In this Danish national TIPY study we aim to evaluate the effect of two years testosterone treatment during puberty in boys with Klinefelter syndrome aged 10 to 14 years. The study is a multi-center, randomized, double-blind, placebo-controlled intervention study. For more details on the study see here
Project on optimizing individual health care for children and adolescents with gender dysphoria
This project aims at mapping the bio-psycho-social profile of Danish children and adolescents with gender incongruence seeking health care at the National Center. It is a multidisciplinary cross-sectional and longitudinal project encompassing many scientific disciplines, i.e. medicine, basic sciences, psychology, psychiatry, sexology, epidemiology and anthropology. The aim is to contribute to an improved individualized and evidence-based health care with long-term sustainability.  
For more information on this study see here.
The Danish Turner Cryopreservation Study – DANTE
DANTE a nationwide study investigating multiple aspects of Turner Syndrome (TS) including ovarian function, the natural history of premature ovarian insufficiency in TS, and potential markers of ovarian reserve in TS patients. TS girls identified as candidates for future fertility treatment based on their fertility potential, will be offered cryopreservation of ovarian tissue. The overarching primary objective is to assess the occurrence of pregnancies, abortions, and live births in women with TS following cryopreservation of ovarian tissue in childhood and autotransplantation in adulthood. For more details on the study see here
Individualised GH therapy in children by Bioactive IGF-I
The aim of the study is to validate bioactive IGF-I as a new tool in monitoring of GH therapy in children. For more information see here.
Long-acting GH in short children born SGA (REAL 5)
REAL 5 is a randomised, multi-centre, open-label, controlled phase 2 study comprising a 26-week main phase and a 4-year extension using weekly GH injections of longacting GH (Somapacitan) versus conventional daily GH injections. The study was initiated i 2019 sponsored by Novo Nordisk and conducted at 38 sites across 12 countries including 1 center in DK (Rigshospitalet)  
ClinicalTrials.gov: NCT03878446.
National investigator, and international rapporteur: Anders Juul
CAHmelia 203/204 – CRF receptor antagonist treatment of CAH patients
This multicenter trial is a Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia (Registries: ClinicalTrials.gov: NCT04457336, EudraCT #: 2019-004764-22).
Two centers in Denmark are part of the trial (Department of growth and reproduction, and Department of endocrinology, Aarhus University Hospital).
National investigator: Anders Juul
Rigshospitalet Growth Hormone Database
All children and adolescents treated with Growth Hormone at the department of Growth and Reproduction are included in this registry. Clinical, biochemical and treatment-related outcomes are reported in the GH registry. More than 1000 GH-treated children with diagnoses like GH deficiency, short SGA children, Turner syndrome, Prader Willi Syndrome, SHOX haploinsufficiency and chronic renal failure are included. The study enables longterm follow up of GH-treated children from a single-center with highly uniform and standardized therapy. The Rigshospitalet GH database received an unrestricted grant from Novo Nordisk Denmark A/S.
Principal investigator: Anders Juul
Rigshospitalet Precocious Puberty Registry
All children referred with a diagnosis of early puberty since 2009 are registered in our retrospective registry (n=1361 girls). Clinical, biochemical and family history are registered. Diagnostic testing, brain MRI and outcome of GnRH therapy are recorded. This single-center study allows detailed phenotyping of CPP patients at baseline as well as longitudinal follow up of diagnostic and therapeutic outcomes in children with CPP. The study is approved by the Danish Healthy Authorities (no. 31-1521-50) and the Danish Data protection Agency (P-2020-145). The CPP study received an unrestricted grant from IPSEN A/S.
Principal Investigator: Anders Juul
Rigshospitalet DSD registry and biobank
All patients with differences in sex development (DSD) which include Klinefelter syndrome, Turner syndrome, CAH, 45X/46XY gonadal dysgenesis, PAIS, CAIS and ambiguous genitalia without DNA findings are included in the registry. The registry enables longterm follow up of rare endocrine disorders. All patient samples in the biobank were taken as part of the clinical follow-up. Access to patient data was approved by the Danish Patient Safety Authority (no. 3-3013-1376/1/) and the Danish Data Protection Agency (no. 2012-58-0004, I-Suite no. 04204).
The international DSD registry (iDSD) is also affiliated to department of Growth and Reproduction, which is accredited as European expert center for rare endocrine disorders (ENDO-ERN).
Principal investigator: Anders Juul
EDMaRC
Dept. of Growth and Reproduction
Copenhagen University Hospital, Rigshospitalet
Blegdamsvej 9
DK-2100 Copenhagen Denmark
edmarc.rigshospitalet@regionh.dk

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