UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001911 |
|---|---|
| Receipt number | 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 12:33:07 |
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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 | Obstetrics 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
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
katsuyuki@poh.osaka-med.ac.jp
Sponsor or person
Institute
Blood Purification Center, Osaka College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002327
