UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007742 |
|---|---|
| Receipt number | 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 10:56:47 |
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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 | Obstetrics 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
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
hasemasa@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009123
