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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013529
Receipt No. 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

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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
Email 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
Email c_popin315@yahoo.co.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
Email

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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015812

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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