UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041833 |
|---|---|
| Receipt number | R000047755 |
| Scientific Title | Effect of low-irritant formulation on adherence to growth hormone therapy in pediatric patients with short statue: An exploratory retrospective observational study. |
| Date of disclosure of the study information | 2020/09/18 |
| Last modified on | 2025/03/24 11:19:15 |
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Basic information
Public title
Effect of low-irritant formulation on adherence to growth hormone therapy in pediatric patients with short statue: An exploratory retrospective observational study.
Acronym
GTL-Adherence
Scientific Title
Effect of low-irritant formulation on adherence to growth hormone therapy in pediatric patients with short statue: An exploratory retrospective observational study.
Scientific Title:Acronym
GTL-Adherence
Region
| Japan |
Condition
Condition
Short statue caused by growth hormone deficiency, Turner syndrome, or SGA (born small for gestational age)
Classification by specialty
| Endocrinology and Metabolism | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
-To retrospectively investigate automatically recorded medication adherence of pediatric patients receiving GH therapy through electronic injector Growjector-L.
-To evaluate effect of low-irritant new formulation of GH (Growject) on medication adherence in comparison with old one.
Basic objectives2
Others
Basic objectives -Others
-To explore factors associated with low adherence to GH therapy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Medication adherence of patients administered new or old formulation of Growject in daily clinical practice.
Key secondary outcomes
-Patients characteristics.
-Time course change in medication adherence.
-Nonadherence-free survival.
-Exploration on factors affecting adherence to GH therapy.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Treatment-naive at the start of GH therapy.
-Aged 3 years or older at the start of GH therapy.
-Using Growjector-L.
-Started GH therapy between September 1, 2017 and January 31, 2021.
-Written informed consent from a legally acceptable representative of the patient, along with informed assent if applicable.
Key exclusion criteria
-Contraindications for GH therapy.
eg, Diabetes, malignancy, (possible) pregnancy.
-Judgement of physicians.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Kashimada |
Organization
Tokyo Medical and Dental University
Division name
Department of Pediatrics and Developmental Biology
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, 1138510, Tokyo
TEL
03-3813-6111
kkashimada.ped@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Takasawa |
Organization
Tokyo Medical and Dental University
Division name
Department of Pediatrics and Developmental Biology
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, 1138510, Tokyo
TEL
03-3813-6111
Homepage URL
ktakasawa.ped@tmd.ac.jp
Sponsor or person
Institute
Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
JCR pharmaceuticals Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Life Science and Bioethics Research Center, Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, 1138510, Tokyo
Tel
03-3813-6111
info.bec@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科歯科大学医学部附属病院をはじめとする全国約10施設
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 18 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37545653/
Number of participants that the trial has enrolled
41
Results
This study enrolled 41 patients with short stature from nine Japanese institutions.
Although cumulative adherence rates remained high throughout the observation period, five patients had low adherence (<85%). Self-selection of GH device and irregular injection schedule significantly affected adherence.
Injection log analysis using an electronic GH device had significant potential to encourage collaborative adherence monitoring with healthcare providers and patients, leading to improved GH adherence.
Results date posted
| 2025 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study enrolled 41 (22 boys) patients with short stature, including 20 with GHD (48.8%), three with TS (7.3%), and 18 with SGA (43.9%) from nine Japanese medical institutions.
Participant flow
Nine patients started the new rhGH formulation (New group). Of the other 32 patients, four were newly started with and continued for more than 12 weeks the prior formulation (Prior group), 23 were switched to the new formulation (Switch group), and five were switched formulations but lost log data when using the prior formulation (Others group).
Adverse events
No adverse events were reported in this study.
Outcome measures
Although cumulative adherence rates remained higher than 95% throughout the observation period, five (12.2%) patients had low adherence (<85%). Subsequently, subgroup and logistic regression analyses for exploring factors affecting adherence revealed that self-selection of GH device and irregular injection schedule (ie, frequent injections after midnight) significantly affected adherence rate (p=0.034 and 0.048, respectively). In addition, higher rates of irregular injections significantly affected low adherence (median[range], 11.26[0.79 ~ 30.50]% vs 0.26[0.00 ~ 33.33]%, p = 0.029).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To retrospectively analyze medication adherence data automatically recorded in electronic GH injector Growjector-L.
Management information
Registered date
| 2020 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047755
