UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013529 |
|---|---|
| Receipt number | R000015812 |
| Scientific Title | A randomized prospective study of changes in trabecular bone structure of osteoporosis patients using Multi-Detector Row Computed Tomography with pharmaceutical intervention |
| Date of disclosure of the study information | 2014/03/29 |
| Last modified on | 2014/03/27 14:33:48 |
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Basic information
Public title
A randomized prospective study of changes in trabecular bone structure of osteoporosis patients using Multi-Detector Row Computed Tomography with pharmaceutical intervention
Acronym
A study of trabecular bone structure using Multi-Detector Row Computed Tomography with pharmaceutical intervention
Scientific Title
A randomized prospective study of changes in trabecular bone structure of osteoporosis patients using Multi-Detector Row Computed Tomography with pharmaceutical intervention
Scientific Title:Acronym
A study of trabecular bone structure using Multi-Detector Row Computed Tomography with pharmaceutical intervention
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess vertebral trabecular bone structure that largely responsible for bone strength and the therapeutic effect of Raloxifene hydrochloride in osteoporotic women using MDCT.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate trabecular bone structure using MDCT before and after 6 month, 1, 2 and 3 years treatment.
Key secondary outcomes
Evaluate bone mineral density using dual-energy x-ray absorptiometry, the evidence of vertebral fracture using X-ray, and bone metabolic markers before and after 6 month, 1, 2 and 3 years treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Alfacalcidol (1mcg)+Ca(400mg) /day, 3 years
Interventions/Control_2
Alfacalcidol (1mcg)+Ca(400mg) +Raloxifene hydrochloride (60mg) /day, 3 years
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
Patients corresponding to all three items below;
1. Patients that meets the primary osteoporosis diagnostic criteria
2. New outpatient
3. Patients who obtained the consent in writing from the patient or the family
Key exclusion criteria
1. Secondary osteoporosis patients
2. Patients who has already been osteoporotic treatment
3. Patients whose serum calcium level is 10.5g/dl (albumin correction value) or more
4. Additional, patients who deemed inappropriate by physician as the object of the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Itoh |
Organization
Tokyo Women's Medical University
Division name
Department of Orthopedic Surgery
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, JAPAN
TEL
03-3353-8111
office@ort.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiharu Ishii |
Organization
Tokyo Women's Medical University
Division name
Department of Orthopedic Surgery
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, JAPAN
TEL
03-3353-8111
Homepage URL
c_popin315@yahoo.co.jp
Sponsor or person
Institute
Tokyo Women's Medical 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
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
東京女子医科大学 整形外科
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2006 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 23 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 27 | Day |
Last modified on
| 2014 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015812
