UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000390 |
|---|---|
| Receipt number | R000000480 |
| Scientific Title | The Effect of Low Dose Hormone Replacement Therapy or Raloxifene on Bone and Lipid Metabolism in Hemodialysis Patients |
| Date of disclosure of the study information | 2006/04/01 |
| Last modified on | 2006/04/01 23:50:19 |
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Basic information
Public title
The Effect of Low Dose Hormone Replacement Therapy or Raloxifene on Bone and Lipid Metabolism in Hemodialysis Patients
Acronym
Low Dose HRT and Raloxifene Trial in Hemodialysis Patients
Scientific Title
The Effect of Low Dose Hormone Replacement Therapy or Raloxifene on Bone and Lipid Metabolism in Hemodialysis Patients
Scientific Title:Acronym
Low Dose HRT and Raloxifene Trial in Hemodialysis Patients
Region
| Japan |
Condition
Condition
Postmenopausal osteopenia in hemodialysis patients
Classification by specialty
| Endocrinology and Metabolism | Nephrology | Obstetrics and Gynecology |
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of hormone replacement therapy and raloxifene on bone, mineral and lipid metabolism in postmenopausal hemodialysis patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in serum calcium, phosphorus, parathyroid hormone, bone markers and lipid metabolism
Key secondary outcomes
Change in bone mineral density at the radius on the side without atrio-venous fistula
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Transdermal low dose estrogen replacement therapy with cyclic administration of medroxyprogesterone acetate at 3-month interval
Interventions/Control_2
Oral administration of raloxifene every two days
Interventions/Control_3
No drug intervention
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
Female
Key inclusion criteria
Postmenopausal hemodialysis patients with prevalent fracture or with a T-score of radial bone mineral density <-1.0 on the side without atrio-venous fistula.
Key exclusion criteria
1. Patients with arteriosclerosis obliterans
2. Patients at high risk of venous thrombosis. i.e. bedridden patients
3. Patients with history of uterine cancer and/or breast cancer.
4. Patients receiving specific treatments other than active vitamin D that affect bone and mineral metabolism. i.e. calcitonin, bisphosphonate, and recombinant human PTH.
Target sample size
39
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
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Dai-Ni Rokushima Clinic
Imai Naika Clinic
Obi Clinic
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
| 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
No longer recruiting
Date of protocol fixation
| 2004 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 04 | Month | 01 | Day |
Last modified on
| 2006 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000480
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
