UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000387 |
|---|---|
| Receipt number | R000000478 |
| Scientific Title | An open label randomized controlled trial on the preemptive risedronate intervention for glucocorticoid-induced osteoporosis in chronic kidney disease patients |
| Date of disclosure of the study information | 2006/04/01 |
| Last modified on | 2006/10/18 14:20:27 |
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Basic information
Public title
An open label randomized controlled trial on the preemptive risedronate intervention for glucocorticoid-induced osteoporosis in chronic kidney disease patients
Acronym
The Preemptive Risedronate Intervention for those Undergoing Steroid therapy with Chronic Kidney Diseases (PRIUS-CKD Study )
Scientific Title
An open label randomized controlled trial on the preemptive risedronate intervention for glucocorticoid-induced osteoporosis in chronic kidney disease patients
Scientific Title:Acronym
The Preemptive Risedronate Intervention for those Undergoing Steroid therapy with Chronic Kidney Diseases (PRIUS-CKD Study )
Region
| Japan |
Condition
Condition
Glucocorticoid-induced osteoporosis in CKD patients
Classification by specialty
| Endocrinology and Metabolism | Nephrology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of risedronate on the bone mineral density and the advantage of concurrent use of active vitamin D in controlling parathyroid function in CKD patients receiving long-term glucocorticoid therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in bone mineral density at one year interval
Key secondary outcomes
Changes in bone turnover markers, PTH, and indices of renal function. Safety. Compliance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Active vitamin D alone (1 year)
Interventions/Control_2
Active vitamin D + risedronate (1 year)
Interventions/Control_3
Risedronate alone (1 year)
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
Outpatients with chronic kidney diseases in the nephrology unit of Osaka University Hospital who have been receiving glucocorticoid (2.5mg/day of prednisolone equivalent or greater) for more than 6 months. Creatinine clearance equal to or over 30 mL/min is required for the inclusion.
Key exclusion criteria
Patients receiving specific treatments that affect bone and mineral metabolism such as SERM, HRT, calcitonin, recombinant human PTH, and other bisphosphonate, except for active vitamin D.
Patients in or expecting pregnancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahito Ito |
Organization
Osaka University School of Medicine
Division name
Department of Nephrology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3632
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahito Ito |
Organization
Osaka University School of Medicine
Division name
Department of Nephrology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3632
Homepage URL
taka@medone.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Nephrology, Osaka University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sanofi Aventis
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
CRG040600074
Org. issuing International ID_1
Cochrane Renal Group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2006 | 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
Completed
Date of protocol fixation
| 2003 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2006 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 04 | Month | 01 | Day |
Last modified on
| 2006 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000478
