UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031290 |
|---|---|
| Receipt number | R000035721 |
| Scientific Title | Efficacy of pamidronate for adult osteogenesis imperfecta: uncontrolled study. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2023/08/21 20:47:56 |
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Basic information
Public title
Efficacy of pamidronate for adult osteogenesis imperfecta: uncontrolled study.
Acronym
Efficacy of pamidronate for adult osteogenesis imperfecta
Scientific Title
Efficacy of pamidronate for adult osteogenesis imperfecta: uncontrolled study.
Scientific Title:Acronym
Efficacy of pamidronate for adult osteogenesis imperfecta
Region
| Japan |
Condition
Condition
Osteogenesis imperfecta
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of pamidronate for adult patients with osteogenesis imperfecta
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change from baseline of lumbar 1-4 bone mineral density at weak 68.
Key secondary outcomes
The change of both femoral neck and radius bone mineral density.
Improvement of bone pain.
Improvement of QOL.
Rate of adverse event.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pamidronate disodium intervenous for drip use; 15mg/day (available up to 30mg/day), 1 infection/day x 3 dats, every 4 months, total 16 months.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with osteogenesis imperfecta according to clinical guideline.
2) out patients
3) patinets who filled out the written informed consent related to the participant of this study.
Key exclusion criteria
1) eGFR less than 30
2) patients who have severe renal or hepatic failure.
3) Patients who have allergy against the drug.
4) Patients who are pregnant.
5) Patients who participated to another clinical study within 4 months.
6) Patients who are very poor condition.
7) Patients who have cardiovascular disease (including QTc >500msec).
8) Patinets who are diagnosed as inappropriate for this study including the results of screening test results.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Fukuoka |
Organization
Kobe University Hospital
Division name
Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2, Kusunoki^cho, Chuo-ku, Kobe City, Hyogo, Japan
TEL
078-382-5861
fukuokah@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Fukuoka |
Organization
Kobe University Hospital
Division name
Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2, Kusunoki^cho, Chuo-ku, Kobe City, Hyogo, Japan
TEL
078-382-5861
Homepage URL
soki@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospita;
Address
7-5-2, Kusunoki^cho, Chuo-ku, Kobe City, Hyogo, Japan
Tel
078-382-6669
chiken@med.kobe-u.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 22 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 22 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 22 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035721
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/02/17 | C180066_290088_PRT1.2_20181223.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/02/17 | 臨床研究登録者識別コードリスト.xlsx |
