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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006519
Receipt No. 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

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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
Email 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
Email shitoshi@juntendo.ac.jp

Sponsor
Institute Division of Nephrology, Department of Internal Medicine, Juntendo University Faculty of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007730

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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