UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000387
Receipt No. 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

* 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 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
Email

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
Email taka@medone.med.osaka-u.ac.jp

Sponsor
Institute Department of Nephrology, Osaka University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000478

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.