UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009586 |
|---|---|
| Receipt number | R000011250 |
| Scientific Title | The additive effect of Eldecalcitol for glucocorticoid induced osteoporosis responding poorly to Alendronate. |
| Date of disclosure of the study information | 2012/12/20 |
| Last modified on | 2014/06/23 13:39:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The additive effect of Eldecalcitol for glucocorticoid induced osteoporosis responding poorly to Alendronate.
Acronym
The additive effect of Eldecalcitol for glucocorticoid induced osteoporosis responding poorly to Alendronate.
Scientific Title
The additive effect of Eldecalcitol for glucocorticoid induced osteoporosis responding poorly to Alendronate.
Scientific Title:Acronym
The additive effect of Eldecalcitol for glucocorticoid induced osteoporosis responding poorly to Alendronate.
Region
| Japan |
Condition
Condition
glucocorticoid induced osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of Alendronate plus Eldecalcitol versus Alendronate alone for glucocorticoid induced osteoporosis responding poorly to Alendronate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline to 12 months in lumbar spine BMD
Key secondary outcomes
Change from baseline to 12 months in total hip BMD
bone turnover markers (TRACP-5b,uNTX, BAP, intact PTH, whole PTH, Sclerostin, OC, ucOC)
incidence of fracture (vertebral fractures, non- vertebral fractures),
blood calcium
urinary calcium
creatinine
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Alendronate (35mg/week)
Interventions/Control_2
Alendronate (35mg/week) + Eldecalcitol (0.75mcg/day)
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. Glucocorticoid induced osteoporosis patients who satisfy one of any conditions as follows :
A: patients whose lumbar spine or total hip BMD have not reached %YAM80 within 4 months.
B: patients who have taken 5mg or more prednisolone per day.
C: patients whose bone turnover markers have been beyond normal ranges.
D: patients whose lumbar spine or total hip BMD have had negative change within 1 year.
E: patients who have experienced at least an incident fracture while on bisphosphonates therapy
2. Patients with informed of consent.
Key exclusion criteria
1. Patients with contraindication for Eldecalcitol treatments
2. Patients who are inappropriate for this study by physicians.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuji Goh |
Organization
Shinko Hospital
Division name
Department of Rheumatic Disease
Zip code
Address
Wakinohamacho,1-4-47, Chuo-ku, Kobe, Hyogo
TEL
078-261-6711
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuji Goh |
Organization
Shinko Hospital
Division name
Department of Rheumatic Disease
Zip code
Address
Wakinohamacho,1-4-47, Chuo-ku, Kobe, Hyogo
TEL
078-2661-6711
Homepage URL
tsuji_goh@shinkohp.or.jp
Sponsor or person
Institute
Department of Rheumatic Disease, Shinko Hospital
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shimane University Faculty of Medicine
DS Pharma Biomedical Co,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 12 | Month | 20 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 20 | Day |
Last modified on
| 2014 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011250
