UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008440 |
|---|---|
| Receipt number | R000009928 |
| Scientific Title | Examination for the effect of combination therapy with raloxifene and eldecalcitol in postmenopausal osteoporotic patients |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2021/03/22 14:54:23 |
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Basic information
Public title
Examination for the effect of combination therapy with raloxifene and eldecalcitol in postmenopausal osteoporotic patients
Acronym
Examination for the effect of combination therapy with raloxifene and eldecalcitol in postmenopausal osteoporotic patients
Scientific Title
Examination for the effect of combination therapy with raloxifene and eldecalcitol in postmenopausal osteoporotic patients
Scientific Title:Acronym
Examination for the effect of combination therapy with raloxifene and eldecalcitol in postmenopausal osteoporotic patients
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Geriatrics | Obstetrics and Gynecology |
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the BMD increase at lumbar spine and improve exercise function in postmenopausal osteoporotic patients who had taken combination therapy with raloxifene and 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
Effect of improve exercise function
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Raloxifene (60mg/day) + eldecalcidol (0.75 µg/day)
Interventions/Control_2
Raloxifene (60mg/day)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Postmenopausal osteoporotic patients.
Patients who are treated with raloxifene for more than one year.
Patients with informed of consent.
Key exclusion criteria
Patients who are diagnosed as contraindication of raloxifene treatments.
Patients who are diagnosed as contraindication of eldecalcitol treatments.
Patients who are inappropriate for this study by physician.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Shiba |
Organization
Kurume University, Medical Department
Division name
Department of Orthopaedic Surgery
Zip code
Address
Asahi-machi 67, Kurume city, Fukuoka, 830-0011, Japan
TEL
0942-31-7568
nshiba@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroo Matsuse |
Organization
Kurume University, Medical Department
Division name
Department of Orthopaedic Surgery
Zip code
Address
Asahi-machi 67, Kurume city, Fukuoka, 830-0011, Japan
TEL
0942-31-7568
Homepage URL
matsuse_hiroh@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University, Medical Department
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
久留米大学病院(福岡県
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | 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
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 15 | Day |
Last modified on
| 2021 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009928
