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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007742
Receipt No. R000009123
Scientific Title Examination for the effect of combination therapy with raloxifene and eldecalcitol in primary osteoporotic patients -Switch from alfacalcidol to eldecalcitol-
Date of disclosure of the study information 2012/04/13
Last modified on 2012/05/09

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Basic information
Public title Examination for the effect of combination therapy with raloxifene and eldecalcitol in primary osteoporotic patients -Switch from alfacalcidol to eldecalcitol-
Acronym Effect of combination therapy with raloxifene and eldecalcitol for osteoporosis -Switch from alfacalcidol to eldecalcitol-
Scientific Title Examination for the effect of combination therapy with raloxifene and eldecalcitol in primary osteoporotic patients -Switch from alfacalcidol to eldecalcitol-
Scientific Title:Acronym Effect of combination therapy with raloxifene and eldecalcitol for osteoporosis -Switch from alfacalcidol to eldecalcitol-
Region
Japan

Condition
Condition Osteoporosis
Classification by specialty
Endocrinology and Metabolism Geriatrics Obsterics and gynecology
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the effect in primary osteoporotic patients undergoing combination therapy with raloxifene and alfacalcidol by switching from alfacalcidol to eldecalcitol
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of lumbar spine bone mineral density
Key secondary outcomes Change of total hip bone mineral density
Number of fracture occurred
Change of bone metabolic markers
Safety

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 Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Raloxifene + alfacalcidol for 48 weeks
Interventions/Control_2 Raloxifene + eldecalcitol for 48 weeks
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) Primary osteoporotic patients
2) Patients who are treated with raloxifene and alfacalcidol for more than 24 weeks
3) Patients with informed of consent
Key exclusion criteria 1) Patients who are diagnosed as contraindication of raloxifene treatments
2) Patients who are diagnosed as contraindication of eldecalcitol treatments
3) Patients who have serum calcium levels of above 10.5mg/dL
4) Patients who have taken osteoporosis treatments other than raloxifene and alfacalcidol
5) Patients who are inappropriate for this study by physician
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoichi Ichimura
Organization Kyorin University
Division name Department of Orthopaedic Surgery
Zip code
Address 6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL 0422-47-5511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaichi Hasegawa
Organization Kyorin University
Division name Department of Orthopaedic Surgery
Zip code
Address 6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL 0422-47-5511
Homepage URL
Email hasemasa@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Yamanashi Hospital of Social Insurance
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
2012 Year 04 Month 13 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 Enrolling by invitation
Date of protocol fixation
2012 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 13 Day
Last modified on
2012 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009123

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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