UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008464 |
|---|---|
| Receipt number | R000009954 |
| Scientific Title | Examination for the effect of eldecalcitol on muscle strength in primary osteoporotic patients |
| Date of disclosure of the study information | 2012/07/18 |
| Last modified on | 2016/02/05 19:46:52 |
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Basic information
Public title
Examination for the effect of eldecalcitol on muscle strength in primary osteoporotic patients
Acronym
Effect of eldecalcitol on muscle strength
Scientific Title
Examination for the effect of eldecalcitol on muscle strength in primary osteoporotic patients
Scientific Title:Acronym
Effect of eldecalcitol on muscle strength
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 determine the effect of eldecalcitol on muscle strength, we perform clinical trial in primary osteoporotic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At baseline and after 24 weeks follow up, the following assessments are done.
back muscle strength, hand grip strength, quadriceps muscle strength
Key secondary outcomes
lumbar spine bone mineral density
hip bone mineral density
25(OH)D
one leg stand test, walking test, timed up and go test, number of falls, active mass, QOL, 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
bisphosphonate + eldecalcitol for 24 weeks
Interventions/Control_2
bisphosphonate for 24 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
| 55 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
1. Primary osteoporotic patients
2. Japanese osteoporotic women aged from 55 to 75
Key exclusion criteria
1. Patients with contraindication for bisphosphonate treatments
2. Patients with contraindication for eldecalcitol treatments
3. Patients who are treated with active vitamin D drugs within 8 weeks
4. Patients who have serum calcium levels of above 10.5mg/dL
5. Patients who are inappropriate for this study by physician
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Saito |
Organization
NTT East Tohoku Hospital
Division name
Orthopedic Surgery
Zip code
Address
Yamato-machi 2-29-1, Wakabayashi-Ku, Sendai, Miyagi, Japan
TEL
022-236-5771
takeshi.s@east.ntt.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Saito |
Organization
NTT East Tohoku Hospital
Division name
Orthopedic Surgery
Zip code
Address
Yamato-machi 2-29-1, Wakabayashi-Ku, Sendai, Miyagi, Japan
TEL
022-236-5945
Homepage URL
takeshi.s@east.ntt.co.jp
Sponsor or person
Institute
NTT East Tohoku Hospital
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
| 2012 | Year | 07 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 12 | 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 | 18 | Day |
Last modified on
| 2016 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009954
