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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN82161629 |
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Date of registration:
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19/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A study on the efficacy of the combination of growth hormone (GH) and gonadotropin releasing hormone analogues (GnRHa) on adult height in children with idiopathic short stature
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Scientific title:
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Date of first enrolment:
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01/10/1993 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN82161629 |
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Study type:
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Interventional |
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Study design:
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Multicentre randomised open label active controlled parallel group trial (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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J.M.
Wit |
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Address:
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Leiden University Medical Center
Department of Pediatrics
P.O. Box 9600
2300 RC
Amsterdam
Netherlands |
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Telephone:
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+31 (0)71 5262824 |
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Email:
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j.m.wit@lumc.nl |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: 40 adolescents in early puberty, with a height <-2 Standard Deviation Score (SDS) or with a height SDS between -1 and -2, but a predicted adult height SDS <-2
Exclusion criteria: Disorders or medication influencing growth
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Small for Gestational Age (SGA), children with persistent short stature
Nutritional, Metabolic, Endocrine
Other endocrine disorders
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Intervention(s)
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Daily injections of Growth Hormone (GH) and monthly injections with GnRHa (Decapeptyl) for 3 years.
Regular controls at the clinic, blood investigations for effect and safety parameters, yearly X-rays of the hand, and yearly psychological assessment.
At final height, growth, psychological assessment, bone mineral density.
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Primary Outcome(s)
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Final height SDS minus initial height SDS
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Secondary Outcome(s)
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1. Final height SDS
2. Final height SDS minus initial height SDS
3. Final height SDS minus target height
4. Body mass index
5. Bone mineral density
6. Quality of life
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Source(s) of Monetary Support
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University Medical Centre Utrecht (UMCU) (Netherlands), Netherlands Organisation for Scientific Research (NWO) (Netherlands)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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