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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001911
Receipt No. R000002327
Scientific Title Beneficial effect of Raloxifene on high turn-over bone in chronic hemodialysis patients
Date of disclosure of the study information 2009/05/01
Last modified on 2015/01/06

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Basic information
Public title Beneficial effect of Raloxifene on high turn-over bone in chronic hemodialysis patients
Acronym Effect of Raloxifene on high turn-over bone in dialysis patients
Scientific Title Beneficial effect of Raloxifene on high turn-over bone in chronic hemodialysis patients
Scientific Title:Acronym Effect of Raloxifene on high turn-over bone in dialysis patients
Region
Japan

Condition
Condition chronic kidney disease
postmenopausal osteoporosis
Classification by specialty
Nephrology Obsterics and gynecology Orthopedics
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In female postmenopausal dialysis patients, postmenopausal osteoporosis is supposed to be another risk factor of bone fracture as well as mineral and bone disorder in chronic kidney disease (CKD-MBD). However, both female and male patients are treated mainly by vitamin D using intact parathyroid hormone (iPTH) levels as an indicator. In this study, the efficacy of Raloxifene, a selective estrogen receptor modulator, on subjects whose bone turn-over is still high even after the regular CKD-MBD therapy will be evaluated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes serum bone alkaline phosphatase (BAP) level
serum bone-specific tartrate-resistant acid phosphatase (TRAP5b) level
Key secondary outcomes serum levels od iPTH, calcium, phosphate, total cholesterol, and triacylglyceride

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 medication of Raloxifene
Interventions/Control_2
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
50 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Postmenopausal hemodialysis patients of 50 years old or over with high serum alkaline phosphatase levels (>= 370 U/L), BAP levels (>= 35.4 U/L), or TRAP-5b levels (>= 4.2 U/L).

Key exclusion criteria 1. Patients prescribed with bisphosphonate, aluminium, lanthanum, cinacalcet.
2. Patients with venous thrombosis or its history.
3. Immobilised patients in long term.
4. Patients with anti-phospholipid
antibody syndrome.
5. Patients in pregnancy (including its possibility) and lactation.
6. Patinets with history of allergy to Raloxifene.
7. Patients with liver dysfunction.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Inoue
Organization Osaka College of Medicine
Division name Blood Purification Center
Zip code
Address 2-7 Takatsuki, Osaka
TEL 072-683-1221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Nagatoya
Organization Osaka Medical College
Division name Blood Purification Center
Zip code
Address 2-7 Takatsuki, Osaka
TEL 072-683-1221
Homepage URL
Email katsuyuki@poh.osaka-med.ac.jp

Sponsor
Institute Blood Purification Center, Osaka College of Medicine
Institute
Department

Funding Source
Organization Blood Purification Center, Osaka College 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

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25504368
Number of participants that the trial has enrolled
Results
Both the BAP and the TACP-5b levels were significantly decreased at week 4. The serum calcium value decreased consistently after the start of raloxifene therapy. The intact parathyroid hormone (iPTH) levels were likely increased at week 4. The ratio of BAP to iPTH levels and the ratio of TRACP-5b to iPTH levels both showed significant decreases over time. During the raloxifene therapy, no thrombosis or other drug-related adverse events developed.
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
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 05 Month 01 Day
Date trial data considered complete
2011 Year 05 Month 01 Day
Date analysis concluded
2011 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 04 Month 27 Day
Last modified on
2015 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002327

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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