UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006519 |
|---|---|
| Receipt number | R000007730 |
| Scientific Title | Effect of risedronate combined with vitamin K2 in patients with osteoporosis due to the steroid therapy |
| Date of disclosure of the study information | 2011/10/11 |
| Last modified on | 2014/10/11 09:53:06 |
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Basic information
Public title
Effect of risedronate combined with vitamin K2 in patients with osteoporosis due to the steroid therapy
Acronym
Efficancy of concurrent use of vitamin K2 with risedronate
Scientific Title
Effect of risedronate combined with vitamin K2 in patients with osteoporosis due to the steroid therapy
Scientific Title:Acronym
Efficancy of concurrent use of vitamin K2 with risedronate
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the safety and efficacy of concurrent use of risedronate with vitamin K2 in patients steroid induced osteoporosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of bone mineral density and serum markers for bone turnover
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Risedronate (52 week)
Interventions/Control_2
Risedronate + vitamin K2 (52 week)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients with osteoporosis diagnosed by criteria for initiation of medical treatment (guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for bone and mineral research 2004)
2. patients acquired imformed consent about this study
Key exclusion criteria
1. Contraindication for risedronate use
2. medicated with Warfarin
3. Using other osteoporosis drugs
(active vitamin D3,SERM, ipriflavone, calcitonin, bisphosphonate)
4. Patients judged inappropriate by attending physisians
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Suzuki |
Organization
Juntendo University Faculty of Medicine
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
Address
Hongo 2-1-1, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-5802-1065
shitoshi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Suzuki |
Organization
Juntendo University Faculty of Medicine
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1065
Homepage URL
shitoshi@juntendo.ac.jp
Sponsor or person
Institute
Division of Nephrology, Department of Internal Medicine, Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Department of Internal Medicine, Juntendo University Faculty of Medicine
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
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
順天堂大学付属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 11 | Day |
Last modified on
| 2014 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007730
