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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000390
Receipt No. 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

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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 Obsterics 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
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 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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000480

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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