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
ISRCTN | ISRCTN82161629 |
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DOI | https://doi.org/10.1186/ISRCTN82161629 |
Secondary identifying numbers | N/A |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 24/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof J.M. Wit
Scientific
Scientific
Leiden University Medical Center
Department of Pediatrics
P.O. Box 9600
Amsterdam
2300 RC
Netherlands
Phone | +31 (0)71 5262824 |
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j.m.wit@lumc.nl |
Study information
Study design | Multicentre randomised open label active controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study acronym | GH+GnRHa study |
Study objectives | A combined treatment of GH and GnRHa for 3 years in short adolescents with relatively early puberty leads to final height gain. |
Ethics approval(s) | Received from local medical ethics committee |
Health condition(s) or problem(s) studied | Small for Gestational Age (SGA), children with persistent short stature |
Intervention | 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. |
Intervention type | Other |
Primary outcome measure | Final height SDS minus initial height SDS |
Secondary outcome measures | 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 |
Overall study start date | 01/10/1993 |
Completion date | 01/07/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Sex | Both |
Target number of participants | 40 |
Key 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 |
Key exclusion criteria | Disorders or medication influencing growth |
Date of first enrolment | 01/10/1993 |
Date of final enrolment | 01/07/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Amsterdam
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Pfizer B.V. (Netherlands) (Pfizer Inc, New York)
Not defined
Not defined
P.O. Box 37
Capelle a/d IJssel
2900 AA
Netherlands
Phone | +31 (0)10 4064200 |
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sigrid.van.den.broek@pfizer.com | |
https://ror.org/02bzf1224 |
Funders
Funder type
Hospital/treatment centre
University Medical Centre Utrecht (UMCU) (Netherlands)
No information available
Netherlands Organisation for Scientific Research (NWO) (Netherlands)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Netherlands Organisation for Scientific Research, Dutch National Scientific Foundation, Dutch National Science Foundation, Dutch Research Council (Nederlandse Organisatie voor Wetenschappelijk Onderzoek), NWO:Nederlandse Organisatie voor Wetenschappelijk Onderzoek, Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWO), Dutch Research Council, Dutch Research Council, Netherlands, NWO
- Location
- Netherlands
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/04/2007 | Yes | No |