UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006964 |
|---|---|
| Receipt number | R000008223 |
| Scientific Title | Examination for the effect of combination therapy with alendronate and eldecalcitol in primary osteoporotic patients :A randomized active comparator study -Switch from alfacalcidol to eldecalcitol- |
| Date of disclosure of the study information | 2011/12/27 |
| Last modified on | 2021/01/02 09:35:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination for the effect of combination therapy with alendronate and eldecalcitol in primary osteoporotic patients :A randomized active comparator study
-Switch from alfacalcidol to eldecalcitol-
Acronym
Examination for the effect of combination therapy with alendronate and eldecalcitol for osteoporosis -Switch from alfacalcidol to eldecalcitol-
Scientific Title
Examination for the effect of combination therapy with alendronate and eldecalcitol in primary osteoporotic patients :A randomized active comparator study
-Switch from alfacalcidol to eldecalcitol-
Scientific Title:Acronym
Examination for the effect of combination therapy with alendronate 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
To examine the BMD increase at lumbar spine in primary osteoporotic patients who had taken combination therapy with alendronate 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
Alendronate (35mg/week) + alfacalcidol (1.0ug/day) for 48 weeks
Interventions/Control_2
Alendronate (35mg/week) + eldecalcitol (0.75ug/day) 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
Male and Female
Key inclusion criteria
(1) Primary osteoporotic patients
(2) Patients who are treated with alendronate and alfacalcidol for more than 24 weeks and less than five years
(3) Patients with informed of consent
Key exclusion criteria
(1) Patients who are diagnosed as contraindication of alendronate treatments
(2) Patients who are diagnosed as contraindication of eldecalcitol treatments
(3) Patients who are treated with glucocorticoid
(4) Patients who have serum calcium levels of above 10.5mg/dL
(5) Patients who have taken osteoporosis treatments other than alendronate and alfacalcidol
(6) 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 | Junji Chiba |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-1-10 Nishiogu, Arakawa, Tokyo, Japan
TEL
03-3810-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Inoue |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-1-10 Nishiogu, Arakawa, Tokyo, Japan
TEL
03-3810-1111
Homepage URL
i-yasuo2@apr.so-net.jp
Sponsor or person
Institute
Tokyo Women's Medical University Medical Center East
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
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
| 2011 | Year | 12 | Month | 27 | 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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2011 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | 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
| 2011 | Year | 12 | Month | 27 | Day |
Last modified on
| 2021 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008223
